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 |
|---|---|---|---|---|---|---|---|---|
| Elbasvir/Grazoprevir | Elbasvir/Grazoprevir Fixed Dose Combination: Evaluate the efficacy of of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12). | 0 | None | 3 | 117 | 69 | 117 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| MELANCHOLIA | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.1 | View |
| FRACTURE OF ANATOMICAL NECK OF HUMERUS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| ATTEMPTED SUICIDE | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.1 | View |