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 @ 9:56 PM
Ignite Modification Date: 2025-12-25 @ 7:34 PM
NCT ID: NCT02066532
Description: As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
Frequency Threshold: 0
Time Frame: Up to 6 years
Study: NCT02066532
Study Brief: Ruxolitinib in Combination With Trastuzumab in Metastatic HER2 Positive 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
Phase 1 and 2: Ruxolitinib/Trastuzumab (25 mg) Ruxolitinib: 25 mg bid on days 1 through 21 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. Trastuzumab: 6 mg/kg every 3 weeks (cycle = 21 days). If no trastuzumab \> 28 days, patients will be initially re-loaded at 8 mg/kg, then 6 mg/kg. 4 None 8 26 26 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bone Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Wound Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nervous System Disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Chest Pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Upper Respiratory Infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Thromboembolic Event NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neoplasms benign, malignant and unspecified (including cysts and polyps) NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT General disorders None View
Muscle weakness, upper limb NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Urinary Incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Eye Disorder NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alanine aminotransferase increase NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bone Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
CD4 lymphocytes decrease NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Chest pain- cardiac NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest wall pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cholesterol high NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Confusion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT General disorders None View
Creatinine increase NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cystitis noninfective NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Edema face NON_SYSTEMATIC_ASSESSMENT General disorders None View
Edema limbs NON_SYSTEMATIC_ASSESSMENT General disorders None View
Ejection fraction decreased NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Electrocardiogram QT corrected interval prolonged NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Flu like symptoms NON_SYSTEMATIC_ASSESSMENT General disorders None View
Gait disturbance NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gastroesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal disorders, other NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroparesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Generalized muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hepatic pain NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hoarseness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hot flashes NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertriglyceridemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypoxia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Infections and infestations, other NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Localized edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Memory impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mucositis oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Muscle weakness upper limb NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nervous system disorders - Other NON_SYSTEMATIC_ASSESSMENT Nervous system disorders 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
Oral pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral motor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Premature menopause NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Psychiatric disorders - Other NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pulmonary edema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rectal mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Renal and urinary disorders - Other NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Reproductive system and breast disorders - Other NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Skin and subcutaneous tissue disorders - Other NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sore throat NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Spasticity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Toothache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Transient ischemic attacks NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tumor pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urinary tract infection 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 General disorders None View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
White blood cell decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
General disorders and administration site conditions - Other, specify NON_SYSTEMATIC_ASSESSMENT General disorders None View
Allergic rhinitis NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ascites NON_SYSTEMATIC_ASSESSMENT General disorders None View
Aspartate aminotransferase increase NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bloating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blood and lymphatic system disorders NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blurred vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View