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 |
|---|---|---|---|---|---|---|---|---|
| Continuation Phase Fluoxetine | Participants received acute phase cognitive therapy and continuation phase pill placebo Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions. Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months. | None | None | 0 | 86 | 0 | 86 | View |
| Continuation Phase Cognitive Therapy | Participants received acute phase and continuation phase cognitive therapy Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions. Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months. | None | None | 0 | 86 | 0 | 86 | View |
| Continuation Phase Pill Placebo | Participants received acute phase cognitive therapy and continuation phase fluoxetine Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions. Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months. | None | None | 0 | 69 | 0 | 69 | View |