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 @ 6:37 PM
Ignite Modification Date: 2025-12-25 @ 4:07 PM
NCT ID: NCT04655157
Description: None
Frequency Threshold: 0
Time Frame: Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
Study: NCT04655157
Study Brief: Safety and Efficacy in Participants With Metastatic BRAF-mutant Melanoma Treated With Encorafenib With and Without Binimetinib in Combination With Nivolumab and Low-dose Ipilimuma
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 (Cohort 1): 300mg Encorafenib + 3mg/kg Nivolumab + 1 mg/kg Ipilimumab Patients will be treated with 300mg encorafenib and 3mg/kg nivolumab and 1 mg/kg ipilimumab (triple therapy). encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway. nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells. ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system. 0 None 1 1 1 1 View
Phase 1 (Cohort 2): 450mg Encorafenib + 45mg Binimetinib + 3mg/kg Nivolumab + 1mg/kg Ipilimumab Patients will be treated with 450mg encorafenib, 45mg binimetinib, 3mg/kg nivolumab and 1mg/kg ipilimumab (quadruple therapy). encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway. nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells. ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system. binimetinib: A small molecule, selective inhibitor of MEK, a central kinase in the tumor-promoting MAPK pathway that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 1 None 1 1 0 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (v5.0) View
Spinal Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (v5.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (v5.0) View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (v5.0) View
Spinal Cord Compression SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (v5.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (v5.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (v5.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (v5.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (v5.0) View
ALT Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (v5.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (v5.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (v5.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (v5.0) View
Lymphocyte decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (v5.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (v5.0) View