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 @ 7:25 PM
Ignite Modification Date: 2025-12-25 @ 5:05 PM
NCT ID: NCT01266603
Description: None
Frequency Threshold: 0
Time Frame: Throughout treatment up to 3 years & 9 months.
Study: NCT01266603
Study Brief: High-Dose Interleukin-2 (HDIL-2), Combined With recMAGE-A3 + AS15 ASCI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
High-dose Interleukin-2 (HDIL-2) + recMAGE-A3 Protein (MAGE-A3 In the induction phase, 300 ug of MAGE-A3 +AS15 were given via intramuscular injection every 2 weeks for 6 cycles and then every 3 weeks for 6 cycles. HDIL-2 was initiated on the day following MAGE-A3 CI immunization or up to eight cycles on weeks 1,3,9,11,18.21,27 and 30 at 720,000 IU/kg every 8 h for up to 14 doses each cycle. Following completion of of the 30-week induction HDIL-2 + MAGE-A3, patients who remained on study were continued on the maintenance MAGE-A3 alone alone given every 6 weeks for 4 cycles, then every 12 weeks for 4 cycles, and then every 24 weeks for 4 cycles. 5 None 1 17 17 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Renal Insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastroperesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Decreased Urinary Output SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Edema SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypermagenesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbunemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Increased Aspartate Aminotransferase SYSTEMATIC_ASSESSMENT Investigations None View
Increased Bilirrubin SYSTEMATIC_ASSESSMENT Investigations None View
Increased Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Investigations None View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Weight Loss SYSTEMATIC_ASSESSMENT Investigations None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Increased Alanine Aminotransferase SYSTEMATIC_ASSESSMENT Investigations None View
Increased Alkaline Phosphatase SYSTEMATIC_ASSESSMENT Investigations None View
Injection Site Reaction SYSTEMATIC_ASSESSMENT General disorders None View
Peripheral Sensory Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View