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 @ 5:06 AM
Ignite Modification Date: 2025-12-26 @ 4:10 AM
NCT ID: NCT01732627
Description: A SR was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered to be related to vaccination. 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 SafAS population.
Frequency Threshold: 5
Time Frame: Unsolicited AE data were collected from Day 0 up to Day 30 post-vaccination. The SRs were collected within 7 days post-vaccination. SAE information was collected throughout the trial (up to 30 days post-vaccination).
Study: NCT01732627
Study Brief: Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older
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 Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0. 0 None 0 199 114 199 View
Group 2: Menomune® A/C/Y/W 135 Vaccine Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0. 0 None 0 100 54 100 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Injection Site Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View