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 |
|---|---|---|---|---|---|---|---|---|
| Fluzone - Trivalent Inactivated Influenza Vaccine | the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur | None | None | 8 | 814 | 0 | 814 | View |
| Flumist - Live-attenuated Influenza Vaccine | live-attenuated influenza vaccine Flumist, manufactured by MedImmune | None | None | 4 | 813 | 0 | 813 | View |
| Placebo | Physiologic saline administered as a nasal spray or intramuscular injection | None | None | 3 | 325 | 0 | 325 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain, vomiting, diarrhea | None | Gastrointestinal disorders | None | View |
| Anorexia | None | Gastrointestinal disorders | None | View |
| Appendicitis, appendectomy | None | Gastrointestinal disorders | None | View |
| Breast Cancer/Mastectomy | None | Reproductive system and breast disorders | None | View |
| Cellulitis left leg | None | Skin and subcutaneous tissue disorders | None | View |
| Cervical cancer | None | Reproductive system and breast disorders | None | View |
| Cholecystitis, cholecystectomy, cholelithiasis | None | Hepatobiliary disorders | None | View |
| Depression/anxiety | None | Nervous system disorders | None | View |
| Head injury bike accident | None | Surgical and medical procedures | None | View |
| Mononucleosis | None | Infections and infestations | None | View |
| Pneumothorax | None | Respiratory, thoracic and mediastinal disorders | None | View |
| surgical repair of torn ACL | None | Musculoskeletal and connective tissue disorders | None | View |
| surgury - remove tumor in left ovary/fallopian tube | None | Reproductive system and breast disorders | None | View |
| Cholecystitis, cholecystectomy, cholelithiasis | None | Hepatobiliary disorders | None | View |
| Appendectomy | None | Gastrointestinal disorders | None | View |