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 | Placebo placebo: placebo tablet given once daily over 60 days | None | None | 0 | 54 | 12 | 54 | View |
| Grass Tablet 75,000 SQ-T | Grass tablet 75,000 Standardized Quality units Tablet (SQ-T) Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days | None | None | 0 | 53 | 26 | 53 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Oral pruritus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Throat irritation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Tongue oedema | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Respiratory tract infection viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Ear pruritus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |