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 @ 12:07 PM
Ignite Modification Date: 2025-12-25 @ 11:58 AM
NCT ID: NCT02971761
Description: None
Frequency Threshold: 0
Time Frame: 36 months from commencement of treatment
Study: NCT02971761
Study Brief: Pembrolizumab and Enobosarm in Treating Patients With Androgen Receptor Positive Metastatic Triple Negative Breast 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
Treatment (Pembrolizumab, Enobosarm) Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Enobosarm: Given PO Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV 8 None 4 18 18 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
10019279-Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
10021038-Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
10016750-Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
10001409-Adult respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
10013963-Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
10002272-Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
10033557-Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
10040741-Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
10040752-Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
10020850-Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE 4.0 View
10021114-Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE 4.0 View
10005886-Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE 4.0 View
eye discomfort SYSTEMATIC_ASSESSMENT Eye disorders CTCAE 4.0 View
10000060-Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
10000081-Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
10005265-Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
10010774-Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
10012318-Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
10012727-Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
10013781-Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
10013946-Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
10013950-Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
10015388-Esophageal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
10016766-Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
10017999-Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
10028813-Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
10047700-Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
10008531-Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
10011914-Death NOS SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
10014222-Edema face SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
10016059-Facial pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
10016256-Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
10016558-Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
10017577-Gait disturbance SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
10033371-Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
10050068-Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
10062466-Localized edema SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
10062501-Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
DROWSINESS SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
10001718-Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE 4.0 View
10005047-Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
10046300-Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
10046571-Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
10048038-Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
stomach flu SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
10016173-Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 4.0 View
10041569-Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 4.0 View
10001551-Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
10003481-Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
10008661-Cholesterol high SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
10011368-Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
10025256-Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
10029366-Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
10035528-Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
10047896-Weight gain SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
10047900-Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
10049182-White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
10002646-Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
10020639-Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
10020647-Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
10020943-Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
10020949-Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
10021005-Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
10021018-Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
10021028-Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
10021038-Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
10021059-Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
INCREASED TRIGLYCERIDES SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
10003239-Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
10003988-Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
10006002-Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
10008496-Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
10016750-Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
10028411-Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
10028836-Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
10033425-Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
10062572-Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
LEFT SHOULDER PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
RIGHT HIP PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
RIGHT KNEE PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
RIGHT THIGH PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
increased muscle mass SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
muscle spasm SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
muscle spasms (back) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
actinic keratosis, hyperplastic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE 4.0 View
10013573-Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
10013911-Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
10019211-Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
10020765-Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
10024264-Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
10034620-Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
10041349-Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
10044565-Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
10002855-Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.0 View
10012378-Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.0 View
10022437-Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.0 View
10024419-Libido decreased SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.0 View
10019450-Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
10037032-Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
10046539-Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
10046593-Urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
10061574-Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
10063057-Cystitis noninfective SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
oliguria (mild) SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
10006298-Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE 4.0 View
10046904-Vaginal dryness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE 4.0 View
10003504-Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
10011224-Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
10013963-Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
10015090-Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
10021143-Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
10028735-Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
10035598-Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
10036402-Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
10036790-Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
10041367-Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
10047924-Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
OBSTRUCTIVE PNEUMONIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
bilateral pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
hemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
rhonchi breath sounds SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
10001760-Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
10013786-Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
10020642-Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
10033474-Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
10037087-Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
10037847-Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
10037868-Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
10054541-Periorbital edema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
stent placement SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAE 4.0 View
10016825-Flushing SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
10020407-Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
10020772-Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
10021097-Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
10025233-Lymphedema SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
10042554-Superficial thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
10043565-Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
bradypnea SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
10014020-Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE 4.0 View
10001367-Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE 4.0 View
10022095-Injection site reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
GENERALIZED MSK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
progressive disease SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE 4.0 View