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: 2025-12-25 @ 1:09 AM
Ignite Modification Date: 2025-12-25 @ 11:20 PM
NCT ID: NCT01266993
Description: None
Frequency Threshold: 5
Time Frame: Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (Month 32 up to Month 69).
Study: NCT01266993
Study Brief: Persistence and Booster Study of GSK Biologicals' Meningococcal Vaccine (GSK134612) in Healthy Children
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 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm. 0 None 0 179 130 179 View
Menjugate Group Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm. 0 None 0 62 48 62 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View