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 @ 2:34 AM
Ignite Modification Date: 2025-12-26 @ 1:10 AM
NCT ID: NCT01124734
Description: Definition and processes the same as clinicaltrials.gov terminology.
Frequency Threshold: 5
Time Frame: Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Study: NCT01124734
Study Brief: High Dose Interleukin-2 Followed by Intermittent Low Dose Temozolomide in Patients With 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
Course 1 Cycle 1 This study is a single arm study. All participants received the same treatment regimen. Participants were given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals. Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg 0 None 1 17 17 17 View
Course 1 Cycle 2 Patients will be given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals. On the day after discharge, patients will be given oral temozolomide at 75 mg/m2 daily for 21 days. Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg Temozolomide: Patients would receive temozolomide at 75 mg/m2 after discharge from receipt of the second cycle of high dose IL-2. Patients would take the medication at bedtime daily. Four weeks after cycle 2 of a course, they would take it for 21 days. 9 None 1 17 17 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTC V4 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTC V4 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Capillary leak syndrome SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTC V4 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC V4 View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC V4 View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders NCI CTC V4 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders NCI CTC V4 View
Abdominal cramping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC V4 View
Alkaline phosphatase increase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCI CTC V4 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCI CTC V4 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC V4 View
Loss of Appetite - Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC V4 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCI CTC V4 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTC V4 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC V4 View
Increased creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTC V4 View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTC V4 View
Dysgeusia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC V4 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC V4 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC V4 View
INR increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC V4 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC V4 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC V4 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTC V4 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC V4 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTC V4 View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC V4 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTC V4 View
Skin hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTC V4 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTC V4 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC V4 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC V4 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC V4 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTC V4 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC V4 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTC V4 View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC V4 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCI CTC V4 View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC V4 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC V4 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC V4 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC V4 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTC V4 View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCI CTC V4 View