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 @ 4:52 PM
Ignite Modification Date: 2025-12-25 @ 2:35 PM
NCT ID: NCT04969250
Description: Participant who withdrew consent was not included in analysis.
Frequency Threshold: 0
Time Frame: 48 weeks
Study: NCT04969250
Study Brief: Vaccination for Recovered Inpatients With COVID-19 (VATICO)
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 I2 Immediate, two doses. Vaccination at study entry and Week 4 Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection 0 None 0 17 0 17 View
Group D1 Deferred, one dose. Vaccination at Week 12 only Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection 0 None 0 16 0 16 View
Group D2 Deferred, two doses. Vaccination at Week 12 and Week 16 Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection 0 None 1 16 0 16 View
Group I1 Immediate, one dose. Vaccination at study entry Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection 1 None 1 16 0 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Aggravation of bicytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Recurrence of COVID-19 infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):