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 @ 1:29 PM
Ignite Modification Date: 2025-12-25 @ 12:32 PM
NCT ID: NCT02106195
Description: The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 was used. The Clinical Symptom and Adverse Event Grading scale was used for grading toxicities.
Frequency Threshold: 0
Time Frame: 12 weeks: up to 4 weeks for screening, 4 weeks of treatment, and 4 weeks of follow-up.
Study: NCT02106195
Study Brief: A Safety and Tolerability Study of Belumosudil (KD025) Treatment in Subjects With Moderately Severe Psoriasis Vulgaris
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Belumosudil 200 mg PO QD Subjects who received belumosudil 200 mg orally daily 0 None 1 8 4 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 16.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 16.0 View
Anastomotic ulcer SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 16.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Transaminase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 16.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 16.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 16.0 View
Anastomotic ulder SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 16.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 16.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 16.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 16.0 View
Rib Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 16.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 16.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 16.0 View
Tooth ache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 16.0 View