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 |
|---|---|---|---|---|---|---|---|---|
| 450 µg/Day Testosterone | 450 micrograms/day transdermal testosterone patch | None | None | 2 | 7 | 4 | 7 | View |
| Placebo | placebo patch | None | None | 2 | 6 | 4 | 6 | View |
| 300 µg/Day Testosterone | 300 micrograms/day transdermal testosterone patch | None | None | 0 | 4 | 2 | 4 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac Failure Congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Chronic Obstructive Pulmonary Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Gastroenteritis Viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Application Site Reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Rhinitis Allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Sinus Congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Cardiac Failure Congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Hyperparathyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (13.0) | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Fungal Skin Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Viral Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Tendon Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (13.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Renal Failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.0) | View |
| Breast Mass | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (13.0) | View |
| Hirsutism | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.0) | View |