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 @ 11:39 PM
Ignite Modification Date: 2025-12-25 @ 9:30 PM
NCT ID: NCT05929651
Description: Analysis was performed on SafAS.
Frequency Threshold: 5
Time Frame: AEs, SAEs and all-cause mortality (deaths) were collected from vaccination (Day 1) up to 30 days post vaccination, 31 days.
Study: NCT05929651
Study Brief: Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MenACYW Conjugate Vaccine Participants who had received at least 1 of 2 priming doses of either Nimenrix® or Menveo® vaccine during infancy as part of their routine immunization before 12 months of age received a single booster dose (0.5 mL) of MenACYW conjugate vaccine as an IM injection at Day 1. 0 None 1 69 45 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 28.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 28.0 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 28.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 28.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 28.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 28.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 28.0 View
Crying SYSTEMATIC_ASSESSMENT General disorders MedDra 28.0 View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDra 28.0 View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDra 28.0 View
Injection Site Swelling SYSTEMATIC_ASSESSMENT General disorders MedDra 28.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDra 28.0 View