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 @ 12:32 AM
Ignite Modification Date: 2025-12-25 @ 10:40 PM
NCT ID: NCT03232567
Description: Adverse events (AEs): counts and percentages of subjects with AEs Day 1 to day 29 and Medically attended AEs (MAEs), serious AEs (SAEs), new-onset chronic illnesses (NCIs) from Day 1 to Day 181
Frequency Threshold: 0
Time Frame: AEs Day 1 to day 29 Medically attended AEs (MAEs), serious AEs (SAEs), new-onset chronic illnesses (NCIs) from Day 1 to Day 181
Study: NCT03232567
Study Brief: Single-ascending-dose Study of the Safety and Immunogenicity of NasoVAX
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NasoVAX Low Dose NasoVAX administered by intranasal spray at a single dose of 1×10(9th) viral particles (vp) versus placebo NasoVAX: Single ascending dose study 0 None 0 15 10 15 View
NasoVAX Medium Dose NasoVAX administered by intranasal spray at a single dose of 1×10(10th) viral particles (vp) versus placebo NasoVAX: Single ascending dose study 0 None 0 15 10 15 View
NasoVAX High Dose NasoVAX administered by intranasal spray at a single dose of 1×10(11th) viral particles (vp) versus placebo NasoVAX: Single ascending dose study 0 None 0 15 10 15 View
Placebo Normal saline administered 0 None 0 15 15 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Any treatment emergent adverse event SYSTEMATIC_ASSESSMENT Product Issues None View