9 SUPPNUM Supplement Num Integer Serial number for supplemental application, if applicable. If no information is available, 4 Number leave blank. 10 SITEID Study Site Identifier Char String Investigator site identifier assigned by the sponsor. 50 11 ARM Description of Char String Plain text label for the name given to an Arm or treatment group as referenced in the Active name and Planned Treatment clinical study report (limit 200 characters). dose (e.g., Active Arm 25mg), Comparator product name (e.g., Drug x), or Placebo 12 SAFPOP Number of Subjects Num Integer Total number of subjects in safety population at a given site by treatment arm. When a 20 in Safety subject has transferred from one site to another, the applicant should handle reporting of Population such subjects consistently across sites, should ensure the subject is counted at only one site, and should include in the define file the reporting convention used. The applicant may opt to further explain the reasons subjects transferred between sites in the BIMO Guide, if a guide will be provided. Reviewer’s 13 SCREEN Number of Subjects Num Integer Total number of subjects screened (consented) at a given site. When a subject has 100 Screened transferred from one site to another, the applicant should handle reporting of such subjects consistently across sites and include the reporting convention used in the define file or the BIMO Guide (if provided). The applicant may opt to further explain Reviewer’s the reasons subjects transferred between sites in the BIMO Guide, if Reviewer’s provided. 14 DISCSTUD Number of Subject Num Integer Number of subjects in the safety population who discontinued from the study. 5 Discons from Study 15 DISCTRT Number of Subject Num Integer Number of subjects in the safety population who discontinued from the study treatment. 10 Discons from Study Treatment
9 SUPPNUM Supplement Number Num Integer Serial number for supplemental application, if applicable. If no information is available, leave blank. 4 10 SITEID Study Site Identifier Char String Investigator site identifier assigned by the sponsor. 50 11 ARM Description of Planned Treatment Arm Char String Plain text label for the name given to an Arm or treatment group as referenced in the clinical study report (limit 200 characters). Active name and dose (e.g., Active 25mg), Comparator product name (e.g., Drug x), or Placebo 12 SAFPOP Number of Subjects in Safety Population Num Integer Total number of subjects in safety population at a given site by treatment arm. When a subject has transferred from one site to another, the applicant should handle reporting of such subjects consistently across sites, should ensure the subject is counted at only one site, and should include in the define file the reporting convention used. The applicant may opt to further explain the reasons subjects transferred between sites in the BIMO Reviewer’s Guide, if a guide will be provided. 20 13 SCREEN Number of Subjects Screened Num Integer Total number of subjects screened (consented) at a given site. When a subject has transferred from one site to another, the applicant should handle reporting of such subjects consistently across sites and include the reporting convention used in the define file or the BIMO Reviewer’s Guide (if provided). The applicant may opt to further explain the reasons subjects transferred between sites in the BIMO Reviewer’s Guide, if provided. 100 14 DISCSTUD Number of Subject Discons from Study Num Integer Number of subjects in the safety population who discontinued from the study. 5 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