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 @ 2:58 PM
Ignite Modification Date: 2025-12-25 @ 1:23 PM
NCT ID: NCT01349959
Description: CTCAE criteria
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT01349959
Study Brief: Azacitidine and Entinostat in Treating Patients With Advanced Breast 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 (Entinostat and Azacitidine) Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring. Azacitidine: Given SC Entinostat: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies 33 None 2 40 6 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Disease Progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (2.0) View
Death SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (2.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Skin Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (2.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View