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 @ 3:29 PM
Ignite Modification Date: 2025-12-25 @ 1:44 PM
NCT ID: NCT02649192
Description: None
Frequency Threshold: 5
Time Frame: 56 days after the final participant was dosed on Day 0.
Study: NCT02649192
Study Brief: Influenza Virus Vaccine Plus Vitamin A and D Supplements for Prevention of Respiratory Virus Infections in Children
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
A&D - S3 Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season 0 None 0 12 4 12 View
Placebo - S3 Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season 0 None 0 14 3 14 View
Placebo - S1 Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season 0 None 0 4 2 4 View
A&D - S2 Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season 0 None 0 22 6 22 View
Placebo - S2 Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season 0 None 0 22 6 22 View
A&D-S1 Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season 0 None 0 5 5 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Left forearm bruise SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Facial trauma/fractured SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View