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: 2025-12-26 @ 10:59 AM
Ignite Modification Date: 2025-12-26 @ 10:59 AM
NCT ID: NCT02752906
Description: A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.
Frequency Threshold: 5
Time Frame: Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination.
Study: NCT02752906
Study Brief: Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine
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 Healthy, meningococcal-vaccine naive adolescents (\>= 15 to \< 18 years) or adults (\>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0. 0 None 5 402 255 402 View
Group 2: Menactra ® Healthy, meningococcal-vaccine naive adolescents (\>= 15 to \< 18 years) or adults (\>= 18 years) received a single dose of Menactra vaccine on Day 0. 0 None 4 407 263 407 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDra 18.0 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 18.0 View
Allergy To Arthropod Sting SYSTEMATIC_ASSESSMENT Immune system disorders MedDra 18.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 18.0 View
Clavicle Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 18.0 View
Major Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 18.0 View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 18.0 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 18.0 View
Intestinal Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDra 18.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDra 18.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 18.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 18.0 View