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 |
|---|---|---|---|---|---|---|---|---|
| Arm A: Dyskeratosis Congenita, Non-Haploidentical Donor | Arm A Dyskeratosis Congenita (DKC) (non-haploidentical donor) | 1 | None | 0 | 12 | 0 | 12 | View |
| Arm B: Severe Aplastic Anemia, Non-Matched Related, Non-Haploidentical Donor | Arm B: Severe Aplastic Anemia (SAA ) (non-matched related, non-haploidentical donor) | 3 | None | 0 | 18 | 0 | 18 | View |
| Arm D: Dyskeratosis Congenita, PTCy Platform | Arm D: Dyskeratosis Congenita (DKC), PTCy platform | 0 | None | 0 | 0 | 0 | 0 | View |
| Arm E: Severe Aplastic Anemia, PTCy Platform | Arm E: Severe Aplastic Anemia (SAA),PTCy platform | 0 | None | 0 | 8 | 0 | 8 | View |
| Arm C: Severe Aplastic Anemia, Matched Related Donor | Arm C: Severe Aplastic Anemia (matched related donor) | 1 | None | 0 | 23 | 0 | 23 | View |