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 |
|---|---|---|---|---|---|---|---|---|
| Nedocromil | Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge | None | None | 0 | 16 | 4 | 16 | View |
| Placebo | Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler | None | None | 0 | 16 | 5 | 16 | View |
| Montelukast | Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge | None | None | 0 | 15 | 3 | 15 | View |
| Mometasone | Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge | None | None | 0 | 15 | 0 | 15 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Presyncope | None | Nervous system disorders | MedDRA (14.0) | View |
| Toothache | None | Gastrointestinal disorders | MedDRA (14.0) | View |
| Influenza Like Illness | None | General disorders | MedDRA (14.0) | View |
| Upper Respiratory Tract Infection | None | Infections and infestations | MedDRA (14.0) | View |
| Joint Sprain | None | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Headache | None | Nervous system disorders | MedDRA (14.0) | View |
| Rhinitis Allergic | None | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Wheezing | None | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |