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 @ 1:21 PM
Ignite Modification Date: 2025-12-25 @ 12:26 PM
NCT ID: NCT01258595
Description: None
Frequency Threshold: 5.00
Time Frame: Adverse events data were collected from the day of vaccination through 28 days post-vaccination.
Study: NCT01258595
Study Brief: A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fluzone® High-Dose Vaccine Group Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0 None None 0 148 130 148 View
Fluzone® Vaccine Group Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0 None None 0 152 110 152 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Solicited Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Solicited Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Solicited Injection Site Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Solicited Injection Site Induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Solicited Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Solicited Shivering SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Solicited Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Solicited Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View