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 @ 4:52 AM
Ignite Modification Date: 2025-12-26 @ 3:53 AM
NCT ID: NCT04490018
Description: SR was an expected AR that was prelisted (i.e., solicited) in the CRF 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 CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
Frequency Threshold: 5
Time Frame: Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
Study: NCT04490018
Study Brief: Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy Adolescents
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 + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. 0 None 0 171 153 171 View
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. 0 None 1 171 151 171 View
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01. 0 None 0 116 112 116 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Type 1 Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Injection Site Bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Injection Site Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View