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 |
|---|---|---|---|---|---|---|---|---|
| Temsirolimus + Bicalutamide | Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks Casodex (bicalutamide) administered 50 mg/day orally (PO) Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942) IUPAC name: (1R,2R,4S)-4-{(2R)-2-\[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido\[2,1-c\]\[1,4\]oxazacyclohentriacontin-3-yl\]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO | None | None | 1 | 5 | 5 | 5 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Colitis | None | Gastrointestinal disorders | CTCAE 4.0 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | None | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Chest pain - cardiac | None | Cardiac disorders | CTCAE v4.0 | View |
| Other-Tachycardia | None | Cardiac disorders | CTCAE v4.0 | View |
| Palpitations | None | Cardiac disorders | CTCAE v4.0 | View |
| Diarrhea | None | General disorders | CTCAE v4.0 | View |
| Nausea | None | Gastrointestinal disorders | CTCAE v4.0 | View |
| Edema, trunk | None | General disorders | CTCAE v4.0 | View |
| Fatigue | None | General disorders | CTCAE v4.0 | View |
| Other-fall | None | General disorders | CTCAE v4.0 | View |
| Increase creatinine | None | Investigations | CTCAE v4.0 | View |
| Increase in HDL | None | Investigations | CTCAE v4.0 | View |
| Increase LDL | None | Investigations | CTCAE v4.0 | View |
| Platelet count decreased | None | Investigations | CTCAE v4.0 | View |
| Weight loss | None | Investigations | CTCAE v4.0 | View |
| Anorexia | None | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hyperglycemia | None | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypertriglyceridemia | None | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypoalbuminemia | None | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypocalcemia | None | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Other-Bilateral Knee pain | None | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Dysgeusia | None | Nervous system disorders | CTCAE v4.0 | View |
| Hematuria | None | Renal and urinary disorders | CTCAE v4.0 | View |
| Urinary incontinence | None | Renal and urinary disorders | CTCAE v4.0 | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Epistaxis | None | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Other-Sinus congestion | None | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Dry Skin | None | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Rash maculo-papular | None | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Constipation | None | Gastrointestinal disorders | CTCAE v4.0 | View |
| Alkaline phosphatase increased | None | Investigations | CTCAE v4.0 | View |
| Cholesterol high | None | Investigations | CTCAE v4.0 | View |
| Increase ALT | None | Investigations | CTCAE v4.0 | View |
| Increase AST | None | Investigations | CTCAE v4.0 | View |
| Hypokalemia | None | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Anxiety | None | Psychiatric disorders | CTCAE v4.0 | View |