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 @ 4:04 AM
Ignite Modification Date: 2025-12-26 @ 3:00 AM
NCT ID: NCT04193202
Description: All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.
Frequency Threshold: 5
Time Frame: Up to 114 days
Study: NCT04193202
Study Brief: Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Gefapixant Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks. 0 None 3 206 105 206 View
Placebo Participants receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks. 1 None 4 209 22 209 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Clavicle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Tonsillar cyst SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ageusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Hypogeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View