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 @ 2:43 PM
Ignite Modification Date: 2025-12-25 @ 1:13 PM
NCT ID: NCT03861559
Description: All participants who received at least one dose of study treatment and had at least one post-baseline evaluation for safety.
Frequency Threshold: 5
Time Frame: Baseline (Day 1) and up to 14 days after study completion/discontinuation for non-serious adverse events and up to an additional 30 days after study completion for serious adverse events (up to 45 days).
Study: NCT03861559
Study Brief: Onset of Action of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray Compared With Placebo in Seasonal Allergic Rhinitis (C93-184)
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 Nasal Spray Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days. 0 None 0 99 13 99 View
Mometasone Furoate Nasal Spray Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days. 0 None 0 101 14 101 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View