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 |
|---|---|---|---|---|---|---|---|---|
| AA4500 0.58 mg | collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints | None | None | 8 | 204 | 196 | 204 | View |
| Placebo | placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints | None | None | 1 | 104 | 25 | 104 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (8.0) | View |
| Complex regional pain syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Ligament disorder | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Panic attack | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.0) | View |
| Pelvi-ureteric obstruction | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (8.0) | View |
| Spinal fusion surgery | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (8.0) | View |
| Tendon rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blister | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Ecchymosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Injection site haemorrhage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Injection site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Injection site pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Injection site swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Lymph node pain | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (8.0) | View |
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (8.0) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Skin laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Tenderness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |