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 |
|---|---|---|---|---|---|---|---|---|
| Certolizumab Pegol | Certolizumab pegol 400 mg for subcutaneous (sc) injection | None | None | 12 | 223 | 48 | 223 | View |
| Placebo | Placebo, saline solution for sc injection | None | None | 8 | 215 | 42 | 215 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| SPLENOMEGALY | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (9.0) | View |
| ABDOMINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| CROHN'S DISEASE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| INTESTINAL OBSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| LARGE INTESTINAL OBSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| PANCREATITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| PROCTALGIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| SMALL INTESTINAL OBSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| PYREXIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| ABSCESS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.0) | View |
| CLOSTRIDIAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.0) | View |
| GASTROENTERITIS VIRAL | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.0) | View |
| HIV INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.0) | View |
| PERIANAL ABSCESS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.0) | View |
| CONTUSION | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.0) | View |
| FISTULA | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | View |
| METASTATIC NEOPLASM | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | View |
| RENAL COLIC | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (9.0) | View |
| BRONCHOSPASM | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| PYREXIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| URINARY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.0) | View |
| ARTHRALGIA | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | View |
| HEADACHE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.0) | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| ABDOMINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |