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 @ 1:02 AM
Ignite Modification Date: 2025-12-25 @ 11:16 PM
NCT ID: NCT00163293
Description: At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
Frequency Threshold: 5
Time Frame: Up to 12 months
Study: NCT00163293
Study Brief: Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ciclesonide 100 µg Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months. None None 2 79 56 79 View
Ciclesonide 200 µg Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months. None None 2 76 55 76 View
Placebo Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months. None None 2 84 56 84 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (Unspecified) View
Arthritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Lobar pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Myringoplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 9.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 9.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 9.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v 9.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v 9.1 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v 9.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA v 9.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 9.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 9.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 9.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 9.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 9.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v 9.1 View