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 @ 5:25 PM
Ignite Modification Date: 2025-12-25 @ 2:59 PM
NCT ID: NCT01232868
Description: Reactogenecity for 7 days post vaccination AE for 30 days SAE for 180 days (None of the SAE were related to the vaccine-One participant had choliangiocarcinoma and bacteremia and multiorgan failure and died 6 months after receiving TIV- another SAE was in a participant with hospitalization for small bowel obstruction with complete recovery)
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT01232868
Study Brief: Systems Biology of Trivalent Influenza Vaccine (TIV) in Young and Elderly
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Age 25-40 Years Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose. None None 0 22 14 22 View
Age ≥65 Years Healthy participants 65 years or older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose. None None 1 44 29 44 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholangiocarcinoma SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (Unspecified) View
Multiorgan Failure SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (Unspecified) View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
Death SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Induration/Swelling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Tenderness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (Unspecified) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
Bruise SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (Unspecified) View