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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
NCT ID:
NCT02852967
Description:
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
Frequency Threshold:
2
Time Frame:
Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Study:
NCT02852967
Study Brief:
A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis
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 QD + Placebo | One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening Belumosudil: Belumosudil tablets Placebo: Placebo tablets matching belumosudil | 1 | None | 1 | 23 | 14 | 23 | View |
| Belumosudil 200 mg BID (Twice Daily) + Placebo | One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening Belumosudil: Belumosudil tablets Placebo: Placebo tablets matching belumosudil | 0 | None | 0 | 22 | 13 | 22 | View |
| Belumosudil 400 mg QD + Placebo | Two belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening Belumosudil: Belumosudil tablets Placebo: Placebo tablets matching belumosudil | 0 | None | 0 | 21 | 14 | 21 | View |
| Belumosudil 600 mg/Day | Two belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening Belumosudil: Belumosudil tablets | 0 | None | 3 | 26 | 16 | 26 | View |
| Placebo | Two matching placebo tablets in the morning and 1 matching placebo tablet in the evening Placebo: Placebo tablets matching belumosudil | 0 | None | 1 | 18 | 11 | 92 | View |
| All Belumosudil | All subjects from all cohorts who received belumosudil | 1 | None | 1 | 92 | 57 | 92 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chronic obstructive pulmonary disease (COPD) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Natural death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Thalamic infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Hypercholesterolemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Blood creatinine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Gastroesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Meniscus injry | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.0 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Alanine aminotransaminase (ALT) increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Ligament pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Tooth fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |