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 @ 11:13 PM
Ignite Modification Date: 2025-12-25 @ 8:49 PM
NCT ID: NCT01086969
Description: None
Frequency Threshold: 5.00
Time Frame: Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
Study: NCT01086969
Study Brief: A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Age 2 to 11 Years Group Participants at age 2 to 11 years on enrollment. None None 0 100 30 100 View
Age 12 to 17 Years Group Participants aged 12 to 17 years at enrollment. None None 0 100 23 100 View
Age 18 to 55 Years Group Participants aged 18 to 55 years at enrollment None None 0 100 38 100 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View