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 @ 12:31 PM
Ignite Modification Date: 2025-12-25 @ 12:09 PM
NCT ID: NCT02052661
Description: The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
Frequency Threshold: 5
Time Frame: Solicited symptoms: during the 4-day (Day 0-3) follow-up period after vaccination Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination SAEs: During the entire study.
Study: NCT02052661
Study Brief: This Study Aims to Determine the Long-term Persistence of Antibodies Against Hepatitis B and to Evaluate the Immunogenicity and Safety of Hepatitis B Vaccine in Adolescents Vaccinated in Infancy With Infanrix™ Hexa
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-B Kinder Group Subjects who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single dose of Engerix-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm. None None 2 300 200 300 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.0 View
Forearm fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Redness SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Gastrointestinal SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View