Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 5:05 AM
Ignite Modification Date: 2025-12-26 @ 4:08 AM
NCT ID: NCT01973218
Description: None
Frequency Threshold: 5
Time Frame: Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
Study: NCT01973218
Study Brief: Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
rMENB Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study None None 2 174 167 175 View
Placebo/MenACWY Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study None None 0 88 63 88 View
Total Total of subjects None None 2 262 230 263 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
GASTROENTERITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
PAROVARIAN CYST NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 17.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
INJECTION SITE ERYTHEMA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
INJECTION SITE INDURATION NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
INJECTION SITE PAIN NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
INJECTION SITE SWELLING NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
MALAISE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
PYREXIA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
NASOPHARYNGITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
EATING DISORDERS NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 17.0 View
ARTHRALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.0 View
MYALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.0 View