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 @ 12:21 AM
Ignite Modification Date: 2025-12-25 @ 10:25 PM
NCT ID: NCT00063258
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)
Study: NCT00063258
Study Brief: Tarceva Surgery for Resectable Stage IIIA(N2) and IIIB (T4 N2) Non-Small-Cell Lung 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
Chemotherapy + Tarceva None None None 1 5 1 5 View
Chemotherapy Alone None None None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemoptysis (Grade 1) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC Version 2.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Cramping (Grade 2) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC Version 2.0 View
Alopecia (Grade 2) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTC Version 2.0 View
Bilirubin Increase (Grade 1) SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCI CTC Version 2.0 View
Diarrhea (Grade 3) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC Version 2.0 View
Dry Skin (Grade 2) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTC Version 2.0 View
Dysphagia (Grade 1) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC Version 2.0 View
Fatigue (Grade 2) SYSTEMATIC_ASSESSMENT General disorders NCI CTC Version 2.0 View
Infection Clinical with Grade 3-4 ANC (Wound) SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTC Version 2.0 View
Nausea (Grade 1) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC Version 2.0 View
Nausea (Grade 3) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC Version 2.0 View
Neuropathy: Sensory (Grade 1) SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTC Version 2.0 View
Pain (Grade 2) SYSTEMATIC_ASSESSMENT General disorders NCI CTC Version 2.0 View
Palpitations (Grade 3) SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTC Version 2.0 View
Rash/Desquamation (Grade 3) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTC Version 2.0 View
Stomatitis (Grade 2) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC Version 2.0 View
Taste Alteration (Grade 2) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC Version 2.0 View
Vomiting (Grade 2) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC Version 2.0 View
Infection with Normal ANC (Bladder -Urinary) Grade 2 SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTC Version 2.0 View
Infection with Normal ANC (Wound) Grade 2 SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTC Version 2.0 View
Myalgia (Grade 3) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTC Version 2.0 View