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 |
|---|---|---|---|---|---|---|---|---|
| Botulinum Toxin Type A | botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe. | None | None | 5 | 158 | 42 | 158 | View |
| Placebo (Normal Saline) | Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe. | None | None | 8 | 157 | 44 | 157 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.0) | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Localised infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Malignant melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Thyroid cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Transitional cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Carotid artery stenosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Leukoplakia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Prostatic specific antigen increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| Haematospermia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (15.0) | View |