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 | Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks. | None | None | 1 | 990 | 0 | 990 | View |
| Montelukast 10 mg | Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks. | None | None | 4 | 1002 | 0 | 1002 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (7.0) | View |
| Joint Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (7.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (7.0) | View |
| Anxiety Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (7.0) | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | View |