Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Condition 1: Combined Only | Participants randomized to baseline (control) arm Condition 1 will view only combined transplant survival outcome information (e.g. transplant survival rate not stratified by number and quality of donor hearts accepted at each center) when making a choice between the two hospitals. | 0 | None | 0 | 38 | 0 | 38 | View |
| Combined 2: Stratified Only | Participants randomized to Condition 2 will view only stratified transplant survival outcome information when making a choice between the two hospitals. Stratified Transplant Survival: The transplant survival rate in the table of outcome statistics is stratified into two groups: (i) patients who received excellent donor organs and (ii) patients who received less than optimal donor organs. Stratified transplant survival is computed from survival rates of transplant patients who received each quality category of organ. excellent transplant survival = \[number of patients surviving after transplant with excellent organ\]/\[number of patients for whom excellent organ was accepted for transplant\] marginal transplant survival = \[number of patients surviving after transplant with marginal organ\]/\[number of patients for whom marginal organ was accepted for transplant\] | 0 | None | 0 | 34 | 0 | 34 | View |