A Study of Ruxolitinib in Patients With Graft-Versus Host Disease

Grade ≥ 3 infections according to the CTCAE v5.0.

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.

Grade ≥ 3 infections according to the CTCAE v5.0.

Odds ratios of infections and their 95% confidence intervals summarized by risk factors for infection.

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.

ORR is defined as the proportion of patients with complete response (CR) or partial response (PR).

ORR is defined as the proportion of patients with CR or PR.

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.

BOR is defined as the proportion of patients with CR or PR at any time point up to Month 12 of treatment.

Overall survival is defined as the time from the start date of treatment with ruxolitinib to the date of death due to any cause.

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).

TTR is defined as the time from the start date of treatment with ruxolitinib to the date of first confirmed response (CR or PR).