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 @ 2:44 PM
Ignite Modification Date: 2025-12-25 @ 1:14 PM
NCT ID: NCT00675259
Description: The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used for grading patients adverse events.
Frequency Threshold: 5
Time Frame: None
Study: NCT00675259
Study Brief: Phase II NCT (Neoadjuvant Chemotherapy) w/ Weekly Abraxane in Combination With Carboplatin & Bevacizumab in 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
Toxicities During Neoadjuvant Chemotherapy None None None 0 33 33 33 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 3.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 3.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 3.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 3.0 View
Wound Complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE version 3.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE version 3.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3.0 View
Infection with normal ANC SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 3.0 View
Peripherial neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 3.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE version 3.0 View
Depressed Mood SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE version 3.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE version 3.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 3.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE version 3.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3.0 View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3.0 View