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 @ 1:34 AM
Ignite Modification Date: 2025-12-25 @ 11:48 PM
NCT ID: NCT04785794
Description: Includes treatment emergent AEs
Frequency Threshold: 5
Time Frame: IP administration until 28 days post-IIV (where interval between IP and IIV was up to 91 days with an average span of 49 days)
Study: NCT04785794
Study Brief: Safety and Immunogenicity of the Sing2016 M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Dose, 65-85 Years of Age Intranasal physiological saline followed by licensed IIV recommended for people 65 years and older Placebo: This group will receive saline placebo administered intranasally on Day 1 followed by IIV at least 28 days later. 0 None 0 37 3 37 View
M2SR Dose, 65-85 Years of Age Intranasal M2SR vaccine followed by licensed IIV recommended for people 65 years and older Sing2016 M2SR H3N2 influenza vaccine: This group will receive a dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally on Day 1 followed by IIV at least 28 days later. 0 None 0 70 2 70 View
Placebo Dose, 50-64 Years of Age Intranasal physiological saline followed by standard, licensed IIV Placebo: This group will receive saline placebo administered intranasally on Day 1 followed by IIV at least 28 days later. 0 None 0 5 1 5 View
M2SR Dose, 50-64 Years of Age Intranasal M2SR vaccine followed by standard, licensed IIV Sing2016 M2SR H3N2 influenza vaccine: This group will receive a dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally on Day 1 followed by IIV at least 28 days later. 0 None 0 10 1 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (23.0) View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (24.0) View
muscle strain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (24.0) View