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 |
|---|---|---|---|---|---|---|---|---|
| Isoniazid | Isoniazid (INH) \~10 mg/kg (7-15 mg/kg), will be administered once daily to infants in INH arm for 12 months. Isoniazid: HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection. | 0 | None | 21 | 150 | 0 | 150 | View |
| No Isoniazid | No INH will be administered to this arm. | 1 | None | 16 | 150 | 0 | 150 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| HIV infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | DAIDS 2.1 | View |
| Pneumonia/URTI | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | DAIDS 2.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | DAIDS 2.1 | View |
| Malaria | SYSTEMATIC_ASSESSMENT | Infections and infestations | DAIDS 2.1 | View |
| Corrective surgery for spina bifida | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | DAIDS 2.1 | View |
| Corrective surgery for cleft palate | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | DAIDS 2.1 | View |
| Corrective surgery for encephalocele | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | DAIDS 2.1 | View |
| Burns | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | DAIDS 2.1 | View |