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 |
|---|---|---|---|---|---|---|---|---|
| Placebo | Identical capsules that look like the RHB-105 product but contain no active ingredient. | None | None | 1 | 41 | 17 | 41 | View |
| RHB-105 | RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule. Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg. | None | None | 1 | 77 | 38 | 77 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | None | Gastrointestinal disorders | MedDRA (16.0) | View |
| Abdominal tenderness | None | Gastrointestinal disorders | MedDRA (16.0) | View |
| Flatulence | None | Gastrointestinal disorders | MedDRA (16.0) | View |
| Headache | None | Nervous system disorders | MedDRA (16.0) | View |
| Dizziness | None | Nervous system disorders | MedDRA (16.0) | View |
| Chromaturia | None | Renal and urinary disorders | MedDRA (16.0) | View |