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 @ 6:58 PM
Ignite Modification Date: 2025-12-25 @ 4:31 PM
NCT ID: NCT02456857
Description: None
Frequency Threshold: 0
Time Frame: 3 years
Study: NCT02456857
Study Brief: Liposomal Doxorubicin, Bevacizumab, and Everolimus in Patients With Locally Advanced TNBC With Tumors Predicted Insensitive to Standard Chemotherapy; A Moonshot Initiative
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Liposomal Doxorubicin + Bevacizumab + Everolimus Liposomal doxorubicin IV 30mg/m2 + Bevacizumab IV (10-15mg/kg) + Everolimus PO 7.5mg 0 None 5 17 15 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Allergic reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
High cholesterol SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Creatinine increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Anxiety SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Insomnia SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypergylcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Nail Loss SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Oral mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View