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 @ 2:12 PM
Ignite Modification Date: 2025-12-25 @ 12:51 PM
NCT ID: NCT00256295
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00256295
Study Brief: Weekly Oxaliplatin and Gemcitabine for Recurrent or Metastatic 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
Gemcitabine Plus Oxaliplatin Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days. Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days None None 6 7 1 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death due to disease progression SYSTEMATIC_ASSESSMENT General disorders None View
Dehydration due to disease progression SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pneumonia due to disease progression SYSTEMATIC_ASSESSMENT Infections and infestations None View
Carotid artery rupture due to disease progression SYSTEMATIC_ASSESSMENT Vascular disorders None View
Grade II Hepatic toxicity SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Broken leg due to fall SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Grade 3 Sinus Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View