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 |
|---|---|---|---|---|---|---|---|---|
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Applied once daily for 7 days to both axilla (1.5 mL to each axilla). | None | None | 0 | 21 | 4 | 21 | View |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Applied once daily for 7 days to one axilla. | None | None | 0 | 21 | 5 | 21 | View |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Applied once daily for 7 days to both axilla (1.5 mL to each axilla). | None | None | 0 | 21 | 6 | 21 | View |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla). | None | None | 0 | 21 | 5 | 21 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Blood triglycerides increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.1) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| Melanocytic naevus | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.1) | View |
| Catheter site inflammation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| Heart rate increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.1) | View |
| Increased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |
| Skin burning sensation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |