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: 2025-12-25 @ 1:33 AM
Ignite Modification Date: 2025-12-25 @ 11:47 PM
NCT ID: NCT02955394
Description: None
Frequency Threshold: 0
Time Frame: 51.78 months
Study: NCT02955394
Study Brief: Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- 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
Fulvestrant Without Enzalutamide 500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) 0 None 1 27 26 27 View
Fulvestrant With Enzalutamide 500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC), plus160mg of Enzalutamide will be given daily. Enzalutamide: 160mg of Enzalutamide will be given daily in conjunction with Fulvestrant. Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) 0 None 3 34 34 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Coronary Artery Disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Alkaline Phosphatase Increase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Immune system disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Papular Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight Gain SYSTEMATIC_ASSESSMENT Investigations None View
decreased activity SYSTEMATIC_ASSESSMENT General disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pulmonary Fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Maculo-papular rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Skin disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urinary issues SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
vaginal dryness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
alanine transaminase increase SYSTEMATIC_ASSESSMENT Investigations None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blurred Vision SYSTEMATIC_ASSESSMENT Eye disorders None View
agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anorgasmia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Edema SYSTEMATIC_ASSESSMENT General disorders None View
Hyperlipidemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Chest Pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Concentration Impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspareunia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Euphoria SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Eye disorders SYSTEMATIC_ASSESSMENT Eye disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Loss of Taste SYSTEMATIC_ASSESSMENT Investigations None View
Muscle pain SYSTEMATIC_ASSESSMENT Investigations None View
Restless Leg Syndrome SYSTEMATIC_ASSESSMENT Investigations None View
Cold intolerance SYSTEMATIC_ASSESSMENT General disorders None View
Neck tightness SYSTEMATIC_ASSESSMENT General disorders None View
restless hands SYSTEMATIC_ASSESSMENT General disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increase Urine Output SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Decreased ROM SYSTEMATIC_ASSESSMENT General disorders None View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Decreased libido SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Weight Loss SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pre-Diabeties SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Appetite Change SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Involuntary movement SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Mucositis Oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Musculoskeletal and connective tissue disorder - Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nervous System Disorders SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Oral Hemorrhage SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Peripheral Sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Personality Change SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vaginal Bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Respiratory issues SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Toothache SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal Discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal Infection SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Chest Wall Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Cognitive Disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Creatinine increased SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal Cramping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View