This study aims to evaluate the safety and effectiveness of Jakavi® (ruxolitinib) in patients with acute graft-versus host disease (GVHD) and chronic GVHD in clinical practice.
Study Type
OBSERVATIONAL
Enrollment
395
Novartis
Tokyo, Japan
RECRUITINGNumber and Percentage of Patients With Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥ 3 Infections
Grade ≥ 3 infections according to the CTCAE v5.0.
Time frame: Up to 1 year
Number and Percentage of Deaths Due to Infection
Time frame: Up to 1 year
Time to First Event
Time to first event is defined as the time from the start date of treatment with ruxolitinib to the first onset date of infection. Grade ≥ 4 infections according to the CTCAE v5.0.
Time frame: Up to 1 year
Number and Percentage of CTCAE Grade ≥ 3 Infections
Grade ≥ 3 infections according to the CTCAE v5.0.
Time frame: Up to 1 year
Odds Ratio of CTCAE Grade ≥ 3 Infections
Odds ratios of infections and their 95% confidence intervals summarized by risk factors for infection.
Time frame: Up to 1 year
Number and Percentage of Patients With Adverse Events Other Than Infections
Time frame: Up to 1 year
Number and Percentage of Patients who Died From Reasons Other Than Infection
Time frame: Up to 1 year
Time to First Onset of Bone-related Events
The time to the first onset is defined as the time from the start date of treatment with ruxolitinib to the first onset date of CTCAE Grade ≥ 4 fracture or bone-related events other than fracture.
Time frame: Up to 1 year
Novartis Pharmaceuticals
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Overall Response Rate (ORR) Among Patients With Acute GVHD
ORR is defined as the proportion of patients with complete response (CR) or partial response (PR).
Time frame: Day 28
Number and Percentage of Stages of Disorder for Each Organ Among Patients With Acute GVHD
Time frame: Baseline, Day 28, up to 1 year
ORR Among Patients With Chronic GVHD
ORR is defined as the proportion of patients with CR or PR.
Time frame: Month 6
Number and Percentage of Chronic GVHD Patients by Response
Response (CR, PR, mixed response, no change, progression) as entered into the database by the physician in accordance with the Japanese Society for Transplantation and Cellular Therapy guidelines for hematopoietic cell transplantation.
Time frame: Baseline, Month 6, up to 1 year
Best Overall Response (BOR)
BOR is defined as the proportion of patients with CR or PR at any time point up to Month 12 of treatment.
Time frame: Baseline, up to 1 year
Overall Survival
Overall survival is defined as the time from the start date of treatment with ruxolitinib to the date of death due to any cause.
Time frame: Up to 1 year
Duration of Response (DOR) Among Chronic GVHD Patients
DOR is defined for patients who achieved a response (CR or PR) by Month 12 of treatment as the time from the date of first documented response by Month 12 to the date of a DOR event (progression of chronic GVHD, death, or initiation of new systemic therapy for chronic GVHD, whichever occurs first).
Time frame: Up to 1 year
Time to Response (TTR) Among Chronic GVHD Patients
TTR is defined as the time from the start date of treatment with ruxolitinib to the date of first confirmed response (CR or PR).
Time frame: Up to 1 year