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
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Postoperative wound complication | None | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Atrial fibrillation | None | Cardiac disorders | MedDRA 11.1 | View |
| Constipation | None | Gastrointestinal disorders | MedDRA 11.1 | View |
| Small intestinal obstruction | None | Gastrointestinal disorders | MedDRA 11.1 | View |
| Pelvic abscess | None | Infections and infestations | MedDRA 11.1 | View |
| Wound infection staphylococcal | None | Infections and infestations | MedDRA 11.1 | View |
| Postoperative ileus | None | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Fluid overload | None | Metabolism and nutrition disorders | MedDRA 11.1 | View |
| Acute respiratory failure | None | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Bronchial secretion retention | None | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Anastomotic leak | None | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal distension | None | Gastrointestinal disorders | MedDRA 11.1 | View |
| Constipation | None | Gastrointestinal disorders | MedDRA 11.1 | View |
| Flatulence | None | Gastrointestinal disorders | MedDRA 11.1 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA 11.1 | View |
| Pyrexia | None | General disorders | MedDRA 11.1 | View |
| Incision site pain | None | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Procedural nausea | None | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Procedural pain | None | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Dizziness | None | Nervous system disorders | MedDRA 11.1 | View |
| Headache | None | Nervous system disorders | MedDRA 11.1 | View |
| Insomnia | None | Psychiatric disorders | MedDRA 11.1 | View |
| Hiccups | None | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Oropharyngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | MedDRA 11.1 | View |
| Ileus | None | Gastrointestinal disorders | MedDRA 11.1 | View |
| Nausea | None | Gastrointestinal disorders | MedDRA 11.1 | View |
| Procedural hypertension | None | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Bladder spasm | None | Renal and urinary disorders | MedDRA 11.1 | View |