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 @ 7:52 PM
Ignite Modification Date: 2025-12-25 @ 5:27 PM
NCT ID: NCT04456504
Description: Adverse Events are reported per dose, 49 participants for the first dose, and 47 of the 49 for the second dose as 2 participants were lost to follow up.
Frequency Threshold: 0
Time Frame: Adverse events data collected while participants are on study, up to 12 weeks
Study: NCT04456504
Study Brief: HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Healthcare Worker - Dose 1 Healthcare worker who has previously received at least 5 doses of hepatitis B vaccine with aluminum adjuvant (Recombivax B or Engerix B) and has an antibody to the hepatitis B surface antigen (antiHBs) that is less than 10 mIU/ml. Recombinant hepatitis B vaccine with CpG adjuvant: Each participant will receive two doses of hepB-CpG separated by one month and blood draw to measure antibody to the hepatitis B surface antigen prior to dose 2 and one month after dose 2. 0 None 0 49 20 49 View
Healthcare Worker - Dose 2 Healthcare worker who has previously received at least 5 doses of hepatitis B vaccine with aluminum adjuvant (Recombivax B or Engerix B) and has an antibody to the hepatitis B surface antigen (antiHBs) that is less than 10 mIU/ml. Recombinant hepatitis B vaccine with CpG adjuvant: Each participant will receive two doses of hepB-CpG separated by one month and blood draw to measure antibody to the hepatitis B surface antigen prior to dose 2 and one month after dose 2. 0 None 0 47 5 47 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site soreness SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE version 5.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE version 5.0 View
Headache SYSTEMATIC_ASSESSMENT General disorders CTCAE version 5.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE version 5.0 View