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 @ 11:03 PM
Ignite Modification Date: 2025-12-25 @ 8:34 PM
NCT ID: NCT00356369
Description: The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Frequency Threshold: 5
Time Frame: Occurrence of solicited local and general symptoms: during the 4-day (Days 0-3) post vaccination period; Occurrence of unsolicited AE(s): up to 31 days after vaccination; Occurrence of SAE(s): from Day 0 up to 6 months after vaccination.
Study: NCT00356369
Study Brief: Study in Adolescents/Adults to Evaluate Non-inferiority&Persistence up to 5 Years of GSK Bio MenACWY Conjugate 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
Nimenrix Group Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region. 0 None 1 374 186 374 View
Mencevax Group Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm. 0 None 0 126 53 126 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Mental disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Costochondritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Any Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Any Redness SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Any Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Any Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Any Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View