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 @ 2:09 AM
Ignite Modification Date: 2025-12-26 @ 12:36 AM
NCT ID: NCT02513160
Description: None
Frequency Threshold: 5
Time Frame: Run-in Period: up to Day -30 to Day 0 Treatment Period: Day 0 to Week 6
Study: NCT02513160
Study Brief: Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BAI 640 mcg/Day Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (80 mcg/inhalation), twice daily for a total daily dose of 640 mcg for the 6 weeks of the double-blind Treatment Period. None None 2 105 5 105 View
MDI 320 mcg/Day Beclomethasone dipropionate metered-dose inhaler (MDI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for the 6 weeks of the double-blind Treatment Period. None None 0 105 10 105 View
Run-in Placebo Pooled breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for up to 30 days of the single-blind Run-in Period. None None 1 713 0 713 View
Placebo Pooled breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for the 6 weeks of the double-blind Treatment Period. None None 0 107 3 107 View
BAI 320 mcg/Day Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for the 6 weeks of the double-blind Treatment Period. None None 0 108 5 108 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vertigo positional SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (16.1) View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.1) View
Intentional overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (16.1) View
Suicidal behaviour SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (16.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.1) View