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 @ 3:28 AM
Ignite Modification Date: 2025-12-26 @ 2:08 AM
NCT ID: NCT02104505
Description: None
Frequency Threshold: 0
Time Frame: 3 months on average
Study: NCT02104505
Study Brief: Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled LPS
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Gamma Tocopherol Gamma Tocopherol 700 mg capsules; 2 capsules daily for 14 days 0 None 0 17 11 17 View
Placebo 700 mg Safflower oil capsules; 2 capsules daily for 14 days 0 None 0 20 14 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cough during CCRE challenge NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diminished sense of taste SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Skin redness NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vagal response NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shortness of breath during sputum induction NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Loose stools SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Loss of appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest tightness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stomach cramps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough during sputum induction NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View