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 @ 10:36 PM
Ignite Modification Date: 2025-12-25 @ 8:08 PM
NCT ID: NCT03476135
Description: SR was an AR observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
Frequency Threshold: 5
Time Frame: SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
Study: NCT03476135
Study Brief: Immunogenicity and Safety of a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine in 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
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62). 0 None 0 42 36 42 View
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62). 0 None 0 49 43 49 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Injection Site Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Otitis Media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View