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 @ 11:56 PM
Ignite Modification Date: 2025-12-25 @ 9:53 PM
NCT ID: NCT00821951
Description: None
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT00821951
Study Brief: Vorinostat in Combination With Palliative Radiotherapy for Patients With 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
Vorinostat and Radiotherapy Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated. None None 0 16 8 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
hypophosphatemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View