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 @ 4:12 PM
Ignite Modification Date: 2025-12-25 @ 2:11 PM
NCT ID: NCT02927366
Description: None
Frequency Threshold: 5
Time Frame: Adverse Events and Serious Adverse Events were collected for the maximum duration of participants' treatment exposure plus any follow up period, approximately 5 months.
Study: NCT02927366
Study Brief: Safety, Pharmacokinetics and Efficacy Study of QCC374 in PAH Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
QCC374 Adult patients with pulmonary arterial hypertension (PAH) on QCC374. All patients were initiated at 0.03 mg BID (Day 1-3), and were up-titrated to next higher dose 0.06 mg BID (Day 4) and increased to 0.12 mg BID (Day 7-14). 0 None 1 6 6 6 View
Placebo Adult patients with pulmonary arterial hypertension (PAH) on placebo matching to QCC374 doses (0.03 mg BID (Day 1-3), 0.06 mg BID (Day 4) and 0.12 mg BID (Day 7-14)). 0 None 0 2 1 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Hangover SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Otitis Media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Head Discomfort SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (21.0) View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Dental Caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Gastrointestinal Disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Pain In Jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View