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: 2025-12-26 @ 10:32 AM
Ignite Modification Date: 2025-12-26 @ 10:32 AM
NCT ID: NCT03600428
Description: Adverse events (AEs), including serious adverse events (SAEs) were recorded on the memory aid and included the need for new prescription or nonprescription medications for the control of asthma, an unscheduled healthcare provider visit or consultation, any other clinically significant event at any point during the study period. The definition of SAEs matched the definition from clinicaltrials.gov.
Frequency Threshold: 5
Time Frame: Within 42 days (until day 43) after vaccination.
Study: NCT03600428
Study Brief: Safety of LAIV4 in Children With Asthma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Live Attenuated Influenza Vaccine (LAIV4) Participants received one dose of quadrivalent live attenuated influenza vaccine via intranasal spray (administer approximately one half of the contents of the single-dose intranasal sprayer into each nostril, each sprayer contains 0.2 mL of vaccine)). Quadrivalent Live Attenuated Influenza Vaccine (LAIV4): 1 dose, 0.2 mL, intranasal administration 0 None 0 74 8 74 View
Inactivated Influenza Vaccine (IIV4) Participants received one dose of quadrivalent inactivated influenza vaccine via intramuscular injection (0.5 mL). Quadrivalent Inactivated Influenza Vaccine (IIV4): 1 dose, 0.5 mL, intramuscular administration 0 None 0 68 10 68 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asthma Exacerbation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View