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 @ 10:13 PM
Ignite Modification Date: 2025-12-25 @ 7:48 PM
NCT ID: NCT02027935
Description: CTCAE v4.0
Frequency Threshold: 0
Time Frame: Baseline up to 2 years
Study: NCT02027935
Study Brief: CD8+ Antigen-Specific T Cells, Cyclophosphamide, Aldesleukin, and Ipilimumab in Treating Patients With Metastatic Melanoma
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 (T Cells, Chemo, Aldesleukin, Ipilimumab) Single dose of cytoxan at 300mg/m2 on Day-2; Day 0 infusion of 10\^10 T cells/2; 14-day course of low-dose s.c. IL-2; Anti-CTLA4 3 mg/kg IV over 90 minutes 24 hrs post T Cell infusion; Anti-CTLA4 q3 weeks 3 mg/kg IV for 4 doses. 1 None 7 7 7 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Investigations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypotention SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death NOS SYSTEMATIC_ASSESSMENT General disorders None View
Skin Infection SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Lymphedema SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eye disorders SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal disordedrs SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General disorders SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hot Flashes SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Post nasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Psychiatric disorders SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Skin and subcutaneous tissue disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin infection SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Watery Eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
Weight Loss SYSTEMATIC_ASSESSMENT Investigations None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypothyrodism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lymphedema SYSTEMATIC_ASSESSMENT Vascular disorders None View
Metabolism and nutrition disorders SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Muscle weakness lower limbs SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders None View
Endocrine disorders SYSTEMATIC_ASSESSMENT Endocrine disorders None View