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 @ 11:48 PM
Ignite Modification Date: 2025-12-25 @ 9:42 PM
NCT ID: NCT02631551
Description: None
Frequency Threshold: 5
Time Frame: The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., screening visit followed by 7-10 days of placebo run-in period and 14 days of treatment.
Study: NCT02631551
Study Brief: Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GSP 301 NS 2 sprays in each nostril twice daily for 14 days 0 None 1 302 0 302 View
Olopatadine HCl NS 2 sprays in each nostril twice daily for 14 days 0 None 0 297 0 297 View
Mometasone Furoate NS 2 sprays in each nostril twice daily for 14 days 0 None 0 294 0 294 View
GSP 301 Placebo NS 2 sprays in each nostril twice daily for 14 days 0 None 0 287 0 287 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 18.1 View
Other Events(If Any):