Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 3:45 PM
Ignite Modification Date: 2025-12-25 @ 1:52 PM
NCT ID: NCT01765192
Description: Safety analysis set: All randomized participants who received at least 1 dose of study drug. Adverse events are reported for 61 and 62 participants in the roflumilast + montelukast (R+M) and placebo + montelukast (P+M) groups, respectively, as 3 participants discontinued prior to receiving R+M and 2 participants discontinued prior to receiving P+M.
Frequency Threshold: 5
Time Frame: Baseline to the end of the study (Days 1-105)
Study: NCT01765192
Study Brief: Roflumilast Plus Montelukast in Adults With Severe 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
Roflumilast Plus Montelukast Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks. None None 0 61 5 61 View
Placebo Plus Montelukast Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks. None None 0 62 0 62 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View