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
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
NCT ID:
NCT01036594
Description:
None
Frequency Threshold:
5
Time Frame:
Up to 5 years
Study:
NCT01036594
Study Brief:
Ketoconazole and Dexamethasone in Prostate Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Ketoconazole + Hydrocortisone | po = oral, tid = 3 times per day, qam = every morning, qom = every evening, bid = twice daily, 1 cycle = 28 days * Ketoconazole: 200mg during first week of study (run-in phase), then 400mg po tid * Hydrocortisone 20mg po qam and 10mg po qpm: If patient has ≥ 30% PSA decline at 12 week evaluation, treatment continues until progressive disease (by RECIST criteria OR by PSAWG criteria) is documented. After that, drug will be discontinued. If patient has \< 30% PSA decline at 12 week evaluation, patient goes off study. | 0 | None | 4 | 32 | 25 | 32 | View |
| Ketoconazole + Dexamethasone | Ketoconazole: 400mg po tid Dexamethasone 0.5mg po bid: If ≥ 30% PSA decline (Prostate-specific antigen) at 12 week evaluation, administration starts when disease progression on Ketoconazole + Hydrocortisone (by RECIST criteria OR by PSAWG criteria) is documented. | 0 | None | 0 | 9 | 5 | 9 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Peripheral arterial ischemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Obstruction, GU - Ureter | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Infection with unknown ANC - Bladder (urinary) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection - Other | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Rash: dermatitis associated with radiation - Radiation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dry mouth/salivary gland (xerostomia) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Taste alteration (dysgeusia) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Mucositis/stomatitis (clinical exam) - Oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Urinary frequency/urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Thrombotic thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS] | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Fatigue (asthenia, lethargy, malaise) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Edema: limb | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| AST, SGOT(serum glutamic oxaloacetic transaminase) increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Abdomen Pain, NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Pain - Back | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Extremity-limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Joint | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Other | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Chest/thorax NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Bronchospasm, wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Pneumonitis/pulmonary infiltrates | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Renal/Genitourinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Perforation, GU - Kidney | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with unknown ANC - Joint | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Mood alteration - Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Cognitive disturbance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Syncope (fainting) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Joint-effusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Osteoporosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Cardiac Arrhythmia - Other | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Supraventricular and nodal arrhythmia - Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae) | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (3.0) | View |
| Peripheral arterial ischemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Hepatobiliary/Pancreas - Other | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (3.0) | View |
| Dermatology - Other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash: hand-foot skin reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |