Adverse Events Module

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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: 2025-12-24 @ 6:48 PM
Ignite Modification Date: 2025-12-25 @ 4:19 PM
NCT ID: NCT00170157
Description: Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
Frequency Threshold: 0
Time Frame: None
Study: NCT00170157
Study Brief: Hormone Therapy and Ipilimumab in Treating Patients With Advanced 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
Entire Study Population All participants (Androgen ablative (AA) therapy + MDX-010 and Androgen ablative (AA) therapy alone the AA Therapy + MDX-010) were grouped together for this outcome. None None 10 110 107 110 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhea-No Colostom SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Hepatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 6 View
Creatinine SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Vision-Blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Pain-Abdominal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 6 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Ischemia/Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Alkaline phosphatase SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Amylase SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Rash/Desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Lymph node pain SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Endocrine SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 6 View
Vision SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Vision-Blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Anal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Colonic hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Diarrhea-No Colostom SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Pain-Abdominal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Constitutional Symptoms SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Edema: Limb SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Pain-Chest SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Rigors SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Hepatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 6 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 6 View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Colon infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Lung (pneumonia) infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Penis infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Skin (cellulites) infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Bruising (in absence of grade 3 or 4 thrombocytopenia) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 6 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Alkaline phosphatase SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Amylase SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Metabolic/Lab SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Bicarbonate SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Extremity-lower necrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Ischemia-Cerebral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Neuro SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Ureteral Obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urinary bladder hemorrhage SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Sinus Reactions SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Decubitus Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Nail Changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Rash/Desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Facial pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Coagulation SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Creatinine SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Prostatic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View