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 @ 12:01 PM
Ignite Modification Date: 2025-12-25 @ 11:57 AM
NCT ID: NCT02154061
Description: None
Frequency Threshold: 0
Time Frame: 365 days
Study: NCT02154061
Study Brief: Systems Biology of Flu Vaccine in Healthy Adults With and Without the Use of Antibiotics
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
IIV Flu Vaccine With Antibiotics This arm will receive antibiotics prior and after IIV administration. Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine. Metronidazole: This is a standard antibiotic Neomycin: This is a standard antibiotic. Vancomycin: This is a standard antibiotic. 0 None 0 16 6 16 View
IIV Flu Vaccine This arm will not take antibiotics in conjunction with IIV. Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine. 0 None 0 17 3 17 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
anal itching NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
URI NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View