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 @ 1:32 PM
Ignite Modification Date: 2025-12-25 @ 12:33 PM
NCT ID: NCT00774995
Description: None
Frequency Threshold: 5
Time Frame: Serious adverse events: During the entire study period i.e. from Day 0 to Month 1; Unsolicited adverse events: During the 31 days (Day 0 to Day 30) post challenge dose.
Study: NCT00774995
Study Brief: Immune Response of Healthy Subjects Who Received Neonatal Vaccination Course With Engerix™-B Vaccine.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig) Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. None None 0 9 1 9 View
Engerix(3-dose)+HBIg Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. None None 0 16 0 16 View
Engerix(4-dose) Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. None None 0 8 0 8 View
Engerix(3-dose) Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. None None 0 16 0 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View