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 |
|---|---|---|---|---|---|---|---|---|
| 2LALERG | Interleukin 1: 17 CH Interleukin 4: 17-27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH Impregnated on lactose saccharose globules (380 mg/capsule) 2LALERG: Homeopathic drug | 0 | None | 1 | 51 | 7 | 51 | View |
| Placebo | Non-impregnated lactose saccharose globules (380 mg/capsule) Placebo: Placebo | 0 | None | 2 | 51 | 7 | 51 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cocaine abuse | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0) | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| Transient ischemic attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Enteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |