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 @ 4:17 PM
Ignite Modification Date: 2025-12-25 @ 2:14 PM
NCT ID: NCT00718666
Description: Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.
Frequency Threshold: 5
Time Frame: Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54).
Study: NCT00718666
Study Brief: The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Toddlers
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 1 Group Subjects who received 1 dose of Nimenrix vaccine at 12 months of age. 0 None 0 38 31 38 View
Nimenrix 2 Group Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. 0 None 0 46 43 46 View
Nimenrix Naive Group Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5. 0 None 1 100 67 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Humerus fracture 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
Gastrointestinal symptoms SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Injection site bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View