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 QD | Placebo capsules, orally, once daily for up to 4 weeks. | None | None | 0 | None | 37 | None | View |
| Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks. | None | None | 2 | None | 55 | None | View |
| Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks. | None | None | 1 | None | 54 | None | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cholecystitis and Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 9.1 | View |
| Non-site Specific Injuries Not Elsewhere Classified (NEC) | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Poisoning and Toxicity | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrointestinal and Abdominal Pains (Excl Oral and Throat) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Nausea and Vomiting Symptoms | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Upper Respiratory Tract Infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Headaches NEC | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Diarrhoea (Excl Infective) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |