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 @ 4:46 PM
Ignite Modification Date: 2025-12-25 @ 2:32 PM
NCT ID: NCT05858450
Description: This observational retrospective study used de-identified data from Optum Clinformatics Database. In this data source, individual identifying information was not available. Minimum criteria for reporting an adverse event could not be met, hence SAEs and other AEs were not planned to be collected and reported.
Frequency Threshold: 0
Time Frame: All-cause mortality: From Day 1 of vaccination till end of follow-up observation period (approx. 5.5 months, data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 [8 days]); SAEs and Other AEs: Not applicable as safety data not collected.
Study: NCT05858450
Study Brief: This Study Intends to Describe the Characteristics of Patients Given the Pfizer-BioNTech Bivalent mRNA COVID-19 Vaccine and Any Commercially Available Influenza Vaccines at the Same Time Versus at Different Times.
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 1a: Same Day COVID-19 Vaccine and SIV, 18-64 Years Participants included in this group were aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023. 110 None 0 0 0 0 View
Group 2a: COVID-19 Vaccine Alone, 18-64 Years Participants included in this group were aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine alone any time between 31 August 2022 and 30 January 2023. 63 None 0 0 0 0 View
Group 3a: SIV Alone, 18-64 Years Participants included in this group were aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received SIV alone any time between 31 August 2022 and 30 January 2023. 794 None 0 0 0 0 View
Group 1b: Same Day COVID-19 Vaccine and SIV, >= 65 Years Participants included in this group were aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV (enhanced) on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023. 2160 None 0 0 0 0 View
Group 2b: COVID-19 Vaccine Alone, >=65 Years Participants included in this group were aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine alone any time between 31 August 2022 and 30 January 2023. 1402 None 0 0 0 0 View
Group 3b: SIV Alone, >=65 Years Participants included in this group were aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received SIV (enhanced) alone any time between 31 August 2022 and 30 January 2023. 12031 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):