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: 2025-12-25 @ 3:24 AM
Ignite Modification Date: 2025-12-26 @ 2:04 AM
NCT ID: NCT00352105
Description: None
Frequency Threshold: 5
Time Frame: For 2 years of the study
Study: NCT00352105
Study Brief: Cisplatin, Fluorouracil, Iressa, and Radiation Therapy Patients With Locally 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
5-FU, Cisplatin, Radiation and Iressa Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity. None None 60 60 55 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
>= Grade 3 dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
>= Grade 3 mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
>=Grade 3:Nausea, vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Death SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Renal Dysfunction SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Grade 1-2 dysphagia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Grade 1-2 :Nausea, vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Grade 1-2 mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View