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 |
|---|---|---|---|---|---|---|---|---|
| Metformin + Insulin | 5 patients to continue on usual type 2 diabetic treatment consisting of 70/30 insulin, metformin and exercise / nutrition counseling. | None | None | 0 | 5 | 0 | 5 | View |
| QR-Bromocriptine + Metformin + Insulin | study drug add-on to usual therapy with insulin + metformin + exercise / nutritional counseling. The study drug is titrated up starting at one 0.8mg tab daily for 1 week, then 2 (0.8mg) tablets for week 2, then 3 tablets for week 3, then 4 tablets for week 4, then 5 tablets for week 5, then six tablets for week 6 (total 4.8). The titration was stopped when the patient reported side effects and the dose was subsequently reduced to the highest tolerable dose at which the side effect did not occur. The patient maintained this dose for the duration of the 24-week treatment period. | None | None | 0 | 7 | 0 | 7 | View |