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 @ 5:19 PM
Ignite Modification Date: 2025-12-25 @ 2:55 PM
NCT ID: NCT03792750
Description: None
Frequency Threshold: 5
Time Frame: First dose and 100 days after last dose of study therapy (Up to approximately 2 years)
Study: NCT03792750
Study Brief: A Study of BMS-986205 Alone and in Combination With Nivolumab in Chinese Patients With Advanced Malignant Solid Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BMS-986205 in Combination With Nivolumab Study treatment starts with a monotherapy therapy 2-week lead-in treatment (Cycle 0) consisting of a single oral daily dose of 100 mg BMS-986205. Followed by combination therapy cycles comprised of an oral daily dose of 100mg BMS-986205 and one dose of 480mg nivolumab administered intravenously Q4W on Day 1 of each treatment cycle up to 12 cycles. 3 None 3 12 11 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood thyroid stimulating hormone decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood thyroid stimulating hormone increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Myoglobin blood increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Neutrophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Thyroxine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Immune-mediated lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Leukoderma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Uveitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View