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 @ 5:49 PM
Ignite Modification Date: 2025-12-25 @ 3:15 PM
NCT ID: NCT03724968
Description: This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Frequency Threshold: 5
Time Frame: Up to 17 months
Study: NCT03724968
Study Brief: Nivolumab Plus Relatlimab or Ipilimumab in Metastatic Melanoma Stratified by MHC-II Expression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm A Nivolumab and Relatlimab Nivolumab: Nivolumab will be given by vein on day 1 of each cycle. Relatlimab: Relatlimab will be given by vein on day 1 of each 28-day cycle 0 None 0 0 0 0 View
Arm B Nivolumab and Ipilimumab Nivolumab: Nivolumab will be given by vein on day 1 of each cycle. Ipilimumab: Ipilimumab will be given by vein on day 1 during cycles 1-4 (cycles are 21 days). 0 None 1 2 2 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders NCI CTCAE Version 5. View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders NCI CTCAE Version 5. View
Hypopituitarism SYSTEMATIC_ASSESSMENT Endocrine disorders NCI CTCAE Version 5. View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders NCI CTCAE Version 5. View
Chills SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE Version 5. View
Limb edema SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE Version 5. View
Fatigue SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE Version 5. View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE Version 5. View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE Version 5. View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE Version 5. View
Weight loss SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE Version 5. View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE Version 5. View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE Version 5. View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE Version 5. View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE Version 5. View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE Version 5. View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE Version 5. View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE Version 5. View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE Version 5. View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE Version 5. View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE Version 5. View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE Version 5. View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE Version 5. View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE Version 5. View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE Version 5. View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE Version 5. View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE Version 5. View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE Version 5. View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE Version 5. View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE Version 5. View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE Version 5. View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTCAE Version 5. View