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: 2025-12-26 @ 1:16 PM
Ignite Modification Date: 2025-12-26 @ 1:16 PM
NCT ID: NCT02058706
Description: None
Frequency Threshold: 5
Time Frame: Adverse Events were assessed up to 2 years.
Study: NCT02058706
Study Brief: LHRH Analogue Therapy With Enzalutamide or Bicalutamide in Treating Patients With Hormone Sensitive 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
Arm A (Enzalutamide and LHRH Analogue Therapy) Patients receive enzalutamide orally PO QD and undergo orchiectomy or receive LHRH analogue therapy (leuprolide acetate, goserelin acetate, or any other FDA approved preparation). Treatment continues in the absence of disease progression or unacceptable toxicity. enzalutamide: Given PO orchiectomy: Undergo orchiectomy or receive LHRH analogue therapy leuprolide acetate: Undergo orchiectomy or receive LHRH analogue therapy goserelin acetate: Undergo orchiectomy or receive LHRH analogue therapy laboratory biomarker analysis: Correlative studies 8 None 17 36 33 36 View
Arm B (Bicalutamide and LHRH Analogue Therapy) Patients receive bicalutamide PO QD and undergo orchiectomy or receive LHRH analogue therapy as in Arm A. Treatment continues in the absence of disease progression or unacceptable toxicity. bicalutamide: Given PO orchiectomy: Undergo orchiectomy or receive LHRH analogue therapy leuprolide acetate: Undergo orchiectomy or receive LHRH analogue therapy goserelin acetate: Undergo orchiectomy or receive LHRH analogue therapy laboratory biomarker analysis: Correlative studies 18 None 16 35 33 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaphylaxis NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atelectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain - cardiac NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT General disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hot flashes NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertriglyceridemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
INR increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Injection site reaction NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Investigations - Other, specify NON_SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Renal and urinary disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory, thoracic and mediastinal disorders NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Restrictive cardiomyopathy NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Upper gastrointestinal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vascular disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight gain NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Weight loss NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blurred vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Bruising NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Confusion NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General disorders and administration site conditions - Other, specify NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hot flashes NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Memory impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Musculoskeletal and connective tissue disorder - Other, specify NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nervous system disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychiatric disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Rash acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Renal and urinary disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Skin and subcutaneous tissue disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Urinary frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight gain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Weight loss NON_SYSTEMATIC_ASSESSMENT Investigations None View
Edema limbs NON_SYSTEMATIC_ASSESSMENT General disorders None View
Erectile dysfunction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Generalized muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View