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 @ 5:25 PM
Ignite Modification Date: 2025-12-25 @ 2:59 PM
NCT ID: NCT03695250
Description: None
Frequency Threshold: 0
Time Frame: All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
Study: NCT03695250
Study Brief: BMS-986205 and Nivolumab as First or Second Line Therapy in Treating Patients With Liver Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (BMS-986205 and Nivolumab) Patients receive IDO1 inhibitor BMS-986205 PO QD on days 1-14 and nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. IDO1 Inhibitor BMS-986205: Given PO Nivolumab: Given IV 4 None 2 8 8 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
AST increase NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Maculopapular rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Alk phos increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
ALT increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Flatulance NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Oral pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
AST increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
TSH elevation NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View