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 @ 10:20 PM
Ignite Modification Date: 2025-12-26 @ 10:20 PM
NCT ID: NCT01852812
Description: The ASaT population consisted of all participants who received at least one dose of study drug. AEs were reported based on the dose of study drug participants received. Data from the two montelukast 5 mg CT groups (6-9 year olds and 10-15 year olds) were pooled for safety analyses.
Frequency Threshold: 5
Time Frame: Up to 14 days after last dose of study drug (Up to 14 weeks)
Study: NCT01852812
Study Brief: Study of the Safety and Pharmacokinetics of Montelukast (MK-0476) in the Treatment of Japanese Pediatric Participants With Perennial Allergic Rhinitis (MK-0476-520)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Montelukast 4 mg OG/1-5 Year Olds Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total) None None 0 51 37 51 View
Montelukast 5 mg CT/6-15 Year Olds Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks None None 0 36 18 36 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Hand-foot-and-mouth disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Arthropod sting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.1 View
Miliaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.1 View