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 @ 11:53 AM
Ignite Modification Date: 2025-12-25 @ 11:54 AM
NCT ID: NCT00490061
Description: acute and late AE assessed at follow up appointments
Frequency Threshold: 5
Time Frame: 2 years
Study: NCT00490061
Study Brief: Lapatinib and Radiation for Stage III-IV Head and Neck Cancer Patients Who Cannot Tolerate Concurrent Chemotherapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Radiotherapy (Radiation) and Lapatinib Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks. None None 6 16 8 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ALT Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Lymphopenia SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (3.0) View
Edema, larynx SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE V 3.0 View
Thrombosis/Thrombus/Embolism SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Hyponatermia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Elevated AST SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Elevated ALK SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Elevated ALT SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Aspiration pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View