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 @ 12:03 PM
Ignite Modification Date: 2025-12-25 @ 11:57 AM
NCT ID: NCT03179761
Description: None
Frequency Threshold: 0
Time Frame: AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
Study: NCT03179761
Study Brief: High vs. Standard Dose Flu Vaccine in Adult Stem Cell Transplant Recipients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group I (HD-TIV) Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later. Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine given intramuscularly Laboratory Biomarker Analysis: Correlative studies 2 None 4 60 45 60 View
Group 2 (SD-QIV) Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later. Quadrivalent Inactivated Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine given intramuscularly Laboratory Biomarker Analysis: Correlative studies 5 None 0 64 45 64 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Viral illness SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Decreased general activity SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Redness/ Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Myalgia/ Body aches SYSTEMATIC_ASSESSMENT General disorders None View
Tenderness SYSTEMATIC_ASSESSMENT General disorders None View
Swelling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View