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 @ 1:49 PM
Ignite Modification Date: 2025-12-25 @ 12:42 PM
NCT ID: NCT00282295
Description: None
Frequency Threshold: 5
Time Frame: Solicited local and general symptoms during the 4-day (Day 0-3) follow-up period, unsolicited AEs during the 31-day (Day 0-30) follow-up period after each vaccination and SAEs throughout the study (Day 0 - Month 2).
Study: NCT00282295
Study Brief: US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Boostrix + Menactra Group Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region. None None 1 446 371 446 View
Boostrix-Menactra Group Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region. None None 0 446 385 446 View
Menactra-Boostrix Group Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region. None None 1 449 358 449 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Extradural hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9.1 View
Facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9.1 View
Leukemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 9.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.1 View
Redness SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.1 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.1 View
Fever (orally) SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.1 View
Gastrointestinal symptoms SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.1 View
Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.1 View