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 @ 8:03 PM
Ignite Modification Date: 2025-12-25 @ 5:36 PM
NCT ID: NCT02819804
Description: None
Frequency Threshold: 0
Time Frame: The patient was monitored for AEs during treatment on the study and for 30 days after the last dose of study treatment (for approximately 40 days in duration).
Study: NCT02819804
Study Brief: Nivolumab and Dasatinib in Treating Patients With Relapsed or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
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 (Dasatinib, Nivolumab) Patients receive dasatinib PO QD on days 1-28 and nivolumab IV over 30 minutes on days 8 and 22 of course 1 and on days 1 and 15 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Dasatinib: Given PO Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies 0 None 1 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.03 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.03 View
Papulopustular rash SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.03 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.03 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.03 View
INR increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.03 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.03 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 4.03 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.03 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.03 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.03 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.03 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.03 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.03 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.03 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.03 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.03 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.03 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.03 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.03 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.03 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.03 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.03 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.03 View