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 @ 3:01 PM
Ignite Modification Date: 2025-12-25 @ 1:25 PM
NCT ID: NCT01890759
Description: None
Frequency Threshold: 5.00
Time Frame: Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
Study: NCT01890759
Study Brief: Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Russian Federation Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection. 0 None 1 100 35 100 View
India Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection. 0 None 3 199 40 199 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abscess limb NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v15 View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v15 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v15 View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v15 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site Tenderness SYSTEMATIC_ASSESSMENT General disorders MedDRA v15 View
Injection site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA v15 View
Injection site Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA v15 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA v15 View
Crying abnormal SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v15 View
Drowsiness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v15 View
Appetite lost SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v15 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v15 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v15 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v15 View