14 DISCSTUD Number of Num Integer Number of subjects in the safety 5 This pertains to subjects that were Subject Discons population who discontinued enrolled after informed consent from Study from the study. was obtained; could capture in ADaM.ADSL.EOSSTT if data were collected. 15 DISCTRT Number of Num Integer Number of subjects in the safety 10 Could capture in ADaM.ADSL if Subject Discons population who discontinued data were collected. from Study from the study treatment. Treatment 18 TRTEFFR Treatment Num Floating Point Summary statistic for each 0, 0.25, 1, Variable on which treatments are Efficacy Result primary efficacy endpoint by 100 compared according to the SAP; treatment arm at a given site. e.g., change from baseline, time to event. 19 TRTEFFS Treatment Num Floating Point Standard deviation of the 0.065 Efficacy Result efficacy result (TRTEFFR) for Standard each primary endpoint by Deviation treatment arm at a given site. If N=1, set to 0. 20 SITEEFFE Site-Specific Num Floating Point Site effect size with the same 0, 0.25, 1, The pre-specified primary Efficacy Effect representation as reported for 100 comparison is the effect size Size the primary efficacy analysis. desired here. 21 SITEEFFS Site-Specific Num Floating Point Standard deviation of the 0.065 Efficacy Effect efficacy effect size Size Standard (SITEEFFE). If N=1, set to 0. Deviation
14 DISCSTUD Number of Subject Discons from Study Num Integer Number of subjects in the safety population who discontinued from the study. 5 This pertains to subjects that were enrolled after informed consent was obtained; could capture in ADaM.ADSL.EOSSTT if data were collected. 15 DISCTRT Number of Subject Discons from Study Treatment Num Integer Number of subjects in the safety population who discontinued from the study treatment. 10 Could capture in ADaM.ADSL if data were collected. 18 TRTEFFR Treatment Efficacy Result Num Floating Point Summary statistic for each primary efficacy endpoint by treatment arm at a given site. 0, 0.25, 1, 100 Variable on which treatments are compared according to the SAP; e.g., change from baseline, time to event. 19 TRTEFFS Treatment Efficacy Result Standard Deviation Num Floating Point Standard deviation of the efficacy result (TRTEFFR) for each primary endpoint by treatment arm at a given site. If N=1, set to 0. 0.065 20 SITEEFFE Site-Specific Efficacy Effect Size Num Floating Point Site effect size with the same representation as reported for the primary efficacy analysis. 0, 0.25, 1, 100 The pre-specified primary comparison is the effect size desired here. 21 SITEEFFS Site-Specific Efficacy Effect Size Standard Deviation Num Floating Point Standard deviation of the efficacy effect size (SITEEFFE). If N=1, set to 0. 0.065
PhUSE_InspectionSiteSelectionDataElements_Reqs_CDISC_Gap_Analysis_2016-05-26.docx