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 @ 4:53 AM
Ignite Modification Date: 2025-12-26 @ 3:53 AM
NCT ID: NCT03973918
Description: None
Frequency Threshold: 0
Time Frame: Up to 3 years
Study: NCT03973918
Study Brief: Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Patients Treated With Encorafenib or Binimetinib in All Cohorts Toxicities with possible, or probable, or definite attribution to encorafenib or binimetinib, or both. Treatment Cohort 1 AA \& GBM Treatment Cohort 2 anaplastic PXAs Treatment Cohort 3 Other Tumors 5 None 2 5 5 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CPK Increase NON_SYSTEMATIC_ASSESSMENT Investigations CTC AE 5.0 View
eye disorder other NON_SYSTEMATIC_ASSESSMENT Eye disorders CTC AE 5.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
VISION DECREASED NON_SYSTEMATIC_ASSESSMENT Eye disorders CTC AE 5.0 View
DYSPHASIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC AE 5.0 View
ALANINE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTC AE 5.0 View
ANEMIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC AE 5.0 View
ASPARTATE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTC AE 5.0 View
BLURRED VISION NON_SYSTEMATIC_ASSESSMENT Eye disorders CTC AE 5.0 View
CPK INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTC AE 5.0 View
DYSURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTC AE 5.0 View
FATIGUE NON_SYSTEMATIC_ASSESSMENT General disorders CTC AE 5.0 View
FLOATERS NON_SYSTEMATIC_ASSESSMENT Eye disorders CTC AE 5.0 View
MUSCULOSKELETAL CONNECTIVE TISSUE DISORDER NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTC AE 5.0 View
MYALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTC AE 5.0 View
PAIN NON_SYSTEMATIC_ASSESSMENT General disorders CTC AE 5.0 View
RASH NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC AE 5.0 View
RETINOPATHY NON_SYSTEMATIC_ASSESSMENT Eye disorders CTC AE 5.0 View
URINARY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTC AE 5.0 View
CK SERUM NON_SYSTEMATIC_ASSESSMENT Investigations CTC AE 5.0 View
INSOMNIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTC AE 5.0 View
WEIGHT GAIN NON_SYSTEMATIC_ASSESSMENT Investigations CTC AE 5.0 View
FEVER NON_SYSTEMATIC_ASSESSMENT General disorders CTC AE 5.0 View