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 @ 7:45 PM
Ignite Modification Date: 2025-12-25 @ 5:22 PM
NCT ID: NCT02749903
Description: None
Frequency Threshold: 0
Time Frame: Up to 30 days post-treatment, up to 32 months
Study: NCT02749903
Study Brief: Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Enzalutamide Patients receive 160 mg enzalutamide orally once daily (1 cycle=28 days). Patients will remain on therapy until progression of disease or development of unacceptable toxicities or patient or physician withdrawal. Patients will undergo radiographic imaging every 2 months while on study treatment in order to determine response. 27 None 15 46 44 46 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Bone infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Infections and infestations - Oth spec SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Musculoskeletal, conn tissue - Oth spec SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Edema cerebral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Nervous system disorders - Oth spec SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Resp, thoracic, mediastinal - Oth spec SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12 View
Cardiac disorders - Other, specify SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12 View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12 View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12 View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12 View
Eye disorders - Other, specify SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Skin and subcut tissue disord - Oth spec SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Skin induration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Gynecomastia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12 View
Reproductive system and breast -Oth spec SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Gum infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Inj, pois and proced complic - Oth spec SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Investigations - Other, specify SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Joint effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Musculoskeletal, conn tissue - Oth spec SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Dysphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Facial nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Libido decreased SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Psychiatric disorders - Other, specify SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Renal and urinary disorders - Oth spec SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Gastrointestinal disorders - Oth spec SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Facial pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Gen disord and admin site conds-Oth spec SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Neck edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View