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 @ 6:58 PM
Ignite Modification Date: 2025-12-25 @ 4:31 PM
NCT ID: NCT00289757
Description: Analyses were performed on the Long-Term (LT) Total Cohort including subjects who returned for the follow-up and who belonged to the Total Cohort in the primary study. For the other AEs only subjects receiving an additional dose were included. Therefore the number of subjects at risk is not consistent with the LT Total Cohort.
Frequency Threshold: 5
Time Frame: Until year 20 for SAEs and within 4-days after additional vaccination for other AEs. During the 30-day (Day 0 to Day 29) follow-up period after additional vaccination.
Study: NCT00289757
Study Brief: Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine, Injected According to 0, 6-month Schedule
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Havrix Group Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up None None 0 78 2 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View