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 @ 4:05 AM
Ignite Modification Date: 2025-12-26 @ 3:01 AM
NCT ID: NCT01897402
Description: Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.
Frequency Threshold: 4
Time Frame: Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3).
Study: NCT01897402
Study Brief: Immunogenicity and Safety of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Test Vaccine NmVac4-A/C/Y/W-135-DT™ conjugate vaccine None None 0 265 173 265 View
US Licensed Vaccine Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine None None 1 260 141 260 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cerebrovascular Accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Blood Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Glomerular Filtration Rate Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tenderness around injection site SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Pain around injection site SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Hardness around injection site SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Swelling around injection site SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Blood Pressure Systolic Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View