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 @ 3:24 AM
Ignite Modification Date: 2025-12-26 @ 2:03 AM
NCT ID: NCT01454505
Description: An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
Frequency Threshold: 5
Time Frame: Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
Study: NCT01454505
Study Brief: Safety and Efficacy of AL-53817 Nasal Spray Solution
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Stage A/AL-53817 AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose None None 0 35 5 35 View
Stage A/Vehicle Vehicle, 1 or 2 sprays per nostril, single dose None None 0 15 2 15 View
Stage B/AL-53817 AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC. None None 0 40 31 40 View
Stage B/Vehicle Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC. None None 0 20 5 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (14.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.0) View
Nasal discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (14.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.0) View
Respiratory rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (14.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.0) View