Table 2.

Summary Description of the ClinicalTrials.gov Results Database Modules

Basic Results Module	Summary Description	Overview of Minimum Required Information
Participant flow	Description of the No. of research participants starting and completing the study, including exclusions and dropouts, for each arm or comparison group (frequently reported as a CONSORT diagram in a journal article)	No. of participants who entered study; and No. of participants who completed study
Baseline characteristics	Demographic and baseline data for the study population and each arm or comparison group (frequently reported as “Table 1” in a journal article)	Overall No. of participants analyzed; age; gender; for all other measures reported: name (and description); unit of measurement; and summary data, total and by arm
Outcome measures and statistical analyses	Table of outcome measure values for each arm/comparison group, including appropriate statistical analyses	For all prespecified primary and secondary outcome measures: name and description; unit of measurement; time frame; analysis population; and summary data, total and by arm
Adverse events (optional prior to September 2009)	Number and frequency of all serious adverse events and other adverse events exceeding a specified frequency threshold in each arm/group, grouped by organ system	For all adverse events reported: adverse event term; organ system; type of assessment (spontaneous vs systematic); and No. of participants affected, No. of participants at risk, and total No. affected, by arm