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 @ 11:25 PM
Ignite Modification Date: 2025-12-25 @ 9:11 PM
NCT ID: NCT00140556
Description: Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
Frequency Threshold: 5
Time Frame: Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Study: NCT00140556
Study Brief: Angiogenic and EGFR Blockade With Curative Chemoradiation for Advanced Head and Neck 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
Entire Study Population None None None 15 28 28 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Vasculitis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dental, periodontal disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hiccough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Mucosal Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Mucositis, Oropharyngeal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Radiation Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Soft Tissue Necrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Weight Loss SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View