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: 2025-12-24 @ 10:14 PM
Ignite Modification Date: 2025-12-25 @ 7:49 PM
NCT ID: NCT02562235
Description: None
Frequency Threshold: 5
Time Frame: From start of study drug up to 2 days after the last dose of study drug in the main study part, up to 24 weeks plus/minus 5 days.
Study: NCT02562235
Study Brief: Riociguat in Children With Pulmonary Arterial Hypertension (PAH)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Riociguat >=6 to <18 Years Participants with age ≥6 to \<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time. 0 None 4 24 15 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pain of skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.1 View
Skin swelling NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.1 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.1 View
Right ventricular failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.1 View
Vascular device infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View