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 |
|---|---|---|---|---|---|---|---|---|
| Caloric Restriction (CR) | 25% caloric restriction Caloric Restriction (CR): Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months | 0 | None | 1 | 143 | 136 | 143 | View |
| Ad Libitum | Ad libitum energy intake Control: Participants continue their current diet for 24 months | 0 | None | 7 | 75 | 72 | 75 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| spontaneous miscarriage | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | View |
| pneumothorax | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| leiomyoma | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| scoliosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| spinal osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| intestinal abscess | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| atrial septal defect | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Excessive bone loss | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| gastrointestinal virus | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| rash | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| muscle strain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| dysmenorrhea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| dizziness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| diarrhea | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| nasal congestion | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| constipation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| toothache | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |