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 @ 12:22 AM
Ignite Modification Date: 2025-12-25 @ 10:26 PM
NCT ID: NCT03205358
Description: SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
Frequency Threshold: 5
Time Frame: Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
Study: NCT03205358
Study Brief: Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine 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
Group 2: NIMENRIX® Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of NIMENRIX® vaccine. 0 None 0 94 53 94 View
Group 1: MenACYW Conjugate Vaccine Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine. 0 None 1 94 49 94 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ligament injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.0) View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Drowsiness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Injection site Tenderness SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View
Loss of appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (17.0) View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.0) View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.0) View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.0) View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.0) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.0) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View
Injection site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Injection site Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View
Abnormal crying SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (17.0) View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (17.0) View