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 @ 2:23 PM
Ignite Modification Date: 2025-12-25 @ 12:59 PM
NCT ID: NCT00442559
Description: None
Frequency Threshold: 5
Time Frame: Up to 12 months
Study: NCT00442559
Study Brief: Montelukast in Mild Asthmatic Children With Allergic Rhinitis (0476-367)
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 Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks. None None 4 100 83 100 View
Inhaled Corticosteroids (ICS) Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks. None None 3 91 70 91 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.0) View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
ASTHMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.0) View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.0) View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.0) View
CHRONIC SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.0) View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.0) View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.0) View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.0) View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.0) View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
NASAL DISCOMFORT SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.0) View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.0) View
PRODUCTIVE COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.0) View
RHINORRHOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.0) View
SNEEZING SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.0) View
UPPER AIRWAY OBSTRUCTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.0) View
WHEEZING SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.0) View