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| ID | Type | Description | Link |
|---|---|---|---|
| CINC424D2301 | Other Identifier | Novartis Pharmaceuticals | |
| 2016-004432-38 | EudraCT Number |
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The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib | Experimental | Ruxolitinib for the treatment period and extension period. |
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| Best Available Therapy | Active Comparator | Best available therapy for the treatment period and extension period, with optional crossover to ruxolitinib after Cycle 6. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug | Ruxolitinib twice daily at the protocol-defined starting dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit | ORR was defined as the percentage of participants in each arm demonstrating a complete response (CR) or partial response (PR) based on chronic GvHD (cGvHD) disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response. Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies. | Cycle 7 Day 1 (each cycle was comprised of 4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Participants With Clinically Relevant Improvement of the Modified Lee cGvHD Symptom Scale Score | To assess improvement of symptoms based on the total symptom score (TSS); a responder was defined as having achieved a clinically relevant reduction from Baseline of the TSS. The scale consists of 30 items in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological). Participants reported their level of symptom "bother" over the previous month on a 5-point likert scale: not at all, slightly, moderately, quite a bit, or extremely. Subscale scores and the summary score range from 0 to 100, with a higher score indicating worse symptoms. |
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Inclusion Criteria:
Have undergone allogeneic stem cell transplantation (alloSCT) from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative, and reduced intensity conditioning are eligible
Evident myeloid and platelet engraftment: Absolute neutrophil count (ANC) > 1000/mm^3 and platelet count > 25,000/ mm^3
Participants with clinically diagnosed moderate to severe cGvHD according to NIH Consensus Criteria prior to randomization:
Participants currently receiving systemic or topical corticosteroids for the treatment of cGvHD for a duration of < 12 months prior to Cycle 1 Day 1 (if applicable), and have a confirmed diagnosis of steroid-refractory cGvHD defined per 2014 NIH consensus criteria irrespective of the concomitant use of a calcineurin inhibitor (CNI), as follows:
Participant must accept to be treated with only one of the following BAT options on Cycle 1 Day 1 (additions and changes are allowed during the course of the study, but only with BAT from the following BAT options): extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, ibrutinib
Exclusion Criteria:
Participants who have received 2 or more systemic treatment for cGvHD in addition to corticosteroids ± CNI for cGvHD
Patients that transition from active aGvHD to cGvHD without tapering off corticosteroids ± CNI and any systemic treatment
* Patients receiving up to 30 mg by mouth once a day of hydrocortisone (i.e., physiologic replacement dose) of corticosteroids are allowed.
Participants who were treated with prior JAK inhibitors for aGvHD; except when the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks prior to Cycle 1 Day 1
Failed prior alloSCT within the past 6 months from Cycle 1 Day 1
Participants with relapsed primary malignancy, or who have been treated for relapse after the alloSCT was performed
Steroid refractory cGvHD occurring after a non-scheduled donor lymphocyte infusion (DLI) administered for preemptive treatment of malignancy recurrence. Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible
Any corticosteroid therapy for indications other than cGvHD at doses > 1 mg/kg/day methylprednisolone or equivalent within 7 days of Cycle 1 Day 1
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| Name | Affiliation | Role |
|---|---|---|
| Rodica Morariu-Zamfir | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Incyte Investigative Site | Tucson | Arizona | 85724 | United States | ||
| Incyte Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42180389 | Derived | Mahmoudjafari Z, Bhatt V, Xue Z, Locatelli F, Socie G, Zeiser R. Clinical considerations for ruxolitinib in the treatment of steroid-refractory acute graft-versus-host disease (GVHD) and steroid-refractory or -dependent chronic GVHD: a plain language summary. Ther Adv Hematol. 2026 May 19;17:20406207261442908. doi: 10.1177/20406207261442908. eCollection 2026. | |
| 40561385 |
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A total of 404 participants were screened, of whom 72 were screen failures and 3 were not randomized for various reasons. Out of the 329 participants randomized, 6 did not receive BAT due to logistical reasons. A total of 329 participants were included in the Full Analysis Set (FAS); 165 were in the ruxolitinib arm and 164 were in the BAT arm.
The study was conducted in 29 countries globally. During the main treatment period, participants were randomly assigned to a ruxolitinib arm or a Best Available Therapy (BAT) arm for 6 cycles of treatment. At the end of Cycle 6, participants in the BAT arm either crossed over to ruxolitinib treatment or entered the survival follow-up phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ruxolitinib | Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg). |
| FG001 | Best Available Therapy | Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| End of Randomization Period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 7, 2021 | Dec 10, 2021 |
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| Extracorporeal photopheresis (ECP) | Drug | Best available therapy (BAT) will be selected by the investigator for each participant. BAT may not include experimental agents (ie, those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements. The BAT in this study will be among the following treatments currently used in this setting (no other types or combinations of BATs are permitted in this study). |
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| Low-dose methotrexate (MTX) | Drug | Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment. |
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| Mycophenolate mofetil (MMF) | Drug | Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment. |
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| mechanistic Target of Rapamycin (mTOR) inhibitors (everolimus or sirolimus) | Drug | Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment. |
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| Infliximab | Drug | Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment. |
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| Rituximab | Drug | Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment. |
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| Pentostatin | Drug | Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment. |
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| Imatinib | Drug | Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment. |
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| Ibrutinib | Drug | Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment. |
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| Baseline; Cycle 7 Day 1 (each cycle was comprised of 4 weeks) |
| Rate of Failure-free Survival (FFS) | Composite time to event endpoint incorporating the following FFS events: (i) relapse or recurrence of underlying disease or death due to underlying disease, (ii) nonrelapse mortality, or (iii) addition or initiation of another systemic therapy for cGvHD. | Baseline to when the last participant reached Cycle 7 Day 1 (each cycle was comprised of 4 weeks) |
| Rate of FFS at Study Completion | Composite time to event endpoint incorporating the following FFS events: (i) relapse or recurrence of underlying disease or death due to underlying disease, (ii) nonrelapse mortality, or (iii) addition or initiation of another systemic therapy for cGvHD. | From Baseline to Last Participant Last Visit (LPLV) (approximately 5 years) |
| Best Overall Response (BOR) at Cycle 7 Day 1 | BOR was defined as the percentage of participants who achieved an overall response (CR+PR) based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response at any time point (up to Cycle 7 Day 1 or the start of additional systemic therapy for cGvHD). Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies. This analysis was based on the primary cutoff date (May 2020). | up to Cycle 7 Day 1 (each cycle was comprised of 4 weeks) |
| BOR During Cross-over Treatment With Ruxolitinib | BOR was defined as the percentage of participants who achieved an overall response (CR+PR) based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response at any time point (up to Cycle 7 Day 1 or the start of additional systemic therapy for cGvHD). Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies. | from Crossover Cycle 1 Day 1 to any time point up to and including Crossover Cycle 7 Day 1 (each cycle was comprised of 4 weeks) |
| ORR at the End of Cycle 3 | ORR was defined as the percentage of participants in each arm demonstrating a CR or PR based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response. Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies. | Cycle 4 Day 1 (each cycle was comprised of 4 weeks) |
| Duration of Response Through Study Completion | DOR was defined as the time from first response until cGvHD progression, death, or the date of change/addition of systemic therapies for cGvHD and as assessed for responders only. Response was based on cGvHD disease assessments (National Institutes of Health consensus criteria). Duration of response was evaluated in participants who achieved a CR or PR at or before Cycle 7 Day 1. The analysis included a larger number of participants than the number of participants who achieved CR or PR at Cycle 7 Day 1 (82 ruxolitinib and 42 BAT) because the analysis took into account not only those participants who achieved CR or PR at Cycle 7 Day 1, but also participants who achieved CR or PR before Cycle 7 Day 1 but who may have lost their response at Cycle 7 Day 1. For this reason, the number of participants in this analysis does not align with the best overall response (BOR) at Cycle 7 Day 1. This analysis was based on the cutoff date upon study completion (December 2022). | from first response to LPLV (approximately 5 years) |
| Overall Survival (OS) | Overall survival was defined as the time from the date of randomization to the date of death due to any cause. | from the date of randomization to the date of death due to any cause up to LPLV (approximately 5 years) |
| Cumulative Incidence of Non-relapse Mortality (NRM) | Defined as the cumulative incidence rate from competing risk analysis for NRM from the date of randomization to the date of death not preceded by underlying disease relapse/recurrence. | Months 3, 6, 12, 18, 24, 30, and 36 |
| Percentage of Participants With a ≥ 50% Reduction in Daily Corticosteroid Dose | All corticosteroid dosages prescribed to the participant and all dose changes during the study were to be recorded for assessment of participants with a ≥ 50% reduction in daily corticosteroid dose. | from Day 15 up to Day 182 |
| Percentage of Participants Successfully Tapered Off of All Corticosteroids | All corticosteroid dosages prescribed to the participant and all dose changes during the study were to be recorded for assessment of participants who successfully tapered off of all corticosteroids. Participants who completely tapered off corticosteroids refer to those who permanently discontinued steroids as per the dose administration panel and who did not restart steroids in the same interval. Participants who were tapered off and continued follow-up were also counted as being tapered off with 0 dose in subsequent intervals until they discontinued from the main treatment period or restarted steroid treatment. | up to Day 179 |
| Cumulative Incidence of Malignancy Relapse/Recurrence (MR) | Defined as the cumulative incidence rate from competing risk analysis of MR from the date of randomization to hematologic malignancy relapse/recurrence. | Months 3, 6, 12, 18, 24, 30, and 36 |
| Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The FACT-BMT is a 50-item self-report questionnaire that measures the effect of a therapy on domains including physical, functional, social/family, and emotional well-being, together with additional concerns relevant for bone marrow transplantation participants. The questions were based on a 5-point Likert scale, where 0 corresponds to "not at all" and 4 corresponds to "very much." The higher the final score, the better the quality of life. The FACT-BMT total score ranges from 0 to 148. | Baseline; up to Cycle 39 Day 1 (each cycle was comprised of 4 weeks) |
| Change From Baseline in EQ-5D-5L | The EQ-5D-5L is a descriptive classification consisting of five dimensions of health: mobility, self-care, usual activities, anxiety/depression, and pain/discomfort. The five-level version (no problems, slight problems, moderate problems, severe problems, and extreme problems) uses a 5-point Likert scale, with 1 being no problems and 5 being extreme problems. | Baseline; up to Cycle 39 Day 1 (each cycle was comprised of 4 weeks) |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions that occurred after the participant's signed informed consent was obtained. Abnormal laboratory values or test results occurring after informed consent constituted adverse events only if they induced clinical signs or symptoms, were considered clinically significant, required therapy (e.g., hematologic abnormality that required transfusion or hematological stem cell support), or required changes in study medication(s). TEAEs were defined as those AEs that started or worsened during the on-treatment period (either randomized or cross-over period). | from Baseline to LPLV (approximately 5 years) |
| Cmax of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses | Cmax was defined as the maximum observed plasma concentration of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule. | Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose |
| AUClast of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses | AUClast was defined as the area under the concentration-time curve up to the last measurable concentration of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule. | Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose |
| AUCinf of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses | AUCinf was defined as the area under the concentration-time curve from time 0 to infinity. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule. | Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose |
| CL/F of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses | CL/F was defined as the oral dose clearance of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule. | Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose |
| Vz/F of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses | Vz/F was defined as the apparent oral dose volume of distribution of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule. | Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose |
| Tmax of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses | tmax was defined as the time to reach the maximum plasma concentration of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule. | Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose |
| t1/2 of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses | t1/2 was defined as the apparent terminal phase disposition half-life of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule. | Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose |
| Utilization of Medical Resources | The percentage of participants with at least one submission to healthcare encounter was assessed. | from Baseline to LPLV (approximately 5 years) |
| Duarte |
| California |
| 31010 |
| United States |
| Incyte Investigative Site | La Jolla | California | 92093-0987 | United States |
| Incyte Investigative Site | Los Angeles | California | 90033 | United States |
| Incyte Investigative Site | New Haven | Connecticut | 06510 | United States |
| Incyte Investigative Site | Wilmington | Delaware | 19803 | United States |
| Incyte Investigative Site | Gainesville | Florida | 32610 | United States |
| Incyte Investigative Site | Tampa | Florida | 33612 | United States |
| Incyte Investigative Site | Chicago | Illinois | 60611 | United States |
| Incyte Investigative Site | Chicago | Illinois | 60612 | United States |
| Incyte Investigative Site | Chicago | Illinois | 60637 | United States |
| Incyte Investigative Site | Maywood | Illinois | 60153 | United States |
| Incyte Investigative Site | Indianapolis | Indiana | 46237 | United States |
| Incyte Investigative Site | Westwood | Kansas | 66205 | United States |
| Incyte Investigative Site | Lexington | Kentucky | 40536 | United States |
| Incyte Investigative Site | Boston | Massachusetts | 02114 | United States |
| Incyte Investigative Site | Boston | Massachusetts | 02215 | United States |
| Incyte Investigative Site | Omaha | Nebraska | 68198-7680 | United States |
| Incyte Investigative Site | Hackensack | New Jersey | 07601 | United States |
| Incyte Investigative Site | New York | New York | 10021 | United States |
| Incyte Investigative Site | New York | New York | 10032 | United States |
| Incyte Investigative Site | New York | New York | 11040 | United States |
| Incyte Investigative Site | Chapel Hill | North Carolina | 27599 | United States |
| Incyte Investigative Site | Durham | North Carolina | 27710 | United States |
| Incyte Investigative Site | Winston-Salem | North Carolina | 27157 | United States |
| Incyte Investigative Site | Cincinnati | Ohio | 45242 | United States |
| Incyte Investigative Site | Cleveland | Ohio | 44106-5048 | United States |
| Incyte Investigative Site | Cleveland | Ohio | 44195 | United States |
| Incyte Investigative Site | Columbus | Ohio | 43210 | United States |
| Incyte Investigative Site | Oklahoma City | Oklahoma | 73104 | United States |
| Incyte Investigative Site | Philadelphia | Pennsylvania | 19104 | United States |
| Incyte Investigative Site | Pittsburgh | Pennsylvania | 15224 | United States |
| Incyte Investigative Site | Pittsburgh | Pennsylvania | 15232 | United States |
| Incyte Investigative Site | Nashville | Tennessee | 37232 | United States |
| Incyte Investigative Site | Dallas | Texas | 75390 | United States |
| Incyte Investigative Site | Houston | Texas | 77030 | United States |
| Incyte Investigative Site | Seattle | Washington | 98109 | United States |
| Incyte Investigative Site | Milwaukee | Wisconsin | 53226 | United States |
| Novartis Investigative Site | Darlinghurst | New South Wales | 2010 | Australia |
| Novartis Investigative Site | Parkville | Victoria | 3002 | Australia |
| Novartis Investigative Site | Innsbruck | Tyrol | 6020 | Austria |
| Novartis Investigative Site | Graz | 8036 | Austria |
| Novartis Investigative Site | Linz | A-4010 | Austria |
| Novartis Investigative Site | Vienna | A-1090 | Austria |
| Novartis Investigative Site | Antwerp | 2060 | Belgium |
| Novartis Investigative Site | Bruges | 8000 | Belgium |
| Novartis Investigative Site | Brussels | 1200 | Belgium |
| Novartis Investigative Site | Ghent | 9000 | Belgium |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Liège | 4000 | Belgium |
| Novartis Investigative Site | Sofia | 1527 | Bulgaria |
| Novartis Investigative Site | Sofia | 1756 | Bulgaria |
| Novartis Investigative Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Novartis Investigative Site | Hamilton | Ontario | L8V 5C2 | Canada |
| Novartis Investigative Site | Ottawa | Ontario | K1H 8L6 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M5G 2M9 | Canada |
| Novartis Investigative Site | Prague | Czech Republic | 128 20 | Czechia |
| Novartis Investigative Site | Hradec Králové | CZE | 500 05 | Czechia |
| Novartis Investigative Site | Prague | 150 06 | Czechia |
| Novartis Investigative Site | Copenhagen | DK-2100 | Denmark |
| Novartis Investigative Site | Odense | DK 5000 | Denmark |
| Novartis Investigative Site | Bordeaux | Aquitaine | 33076 | France |
| Novartis Investigative Site | Amiens Cedex1 | 80054 | France |
| Novartis Investigative Site | Caen | 14033 | France |
| Novartis Investigative Site | Lille | 59037 | France |
| Novartis Investigative Site | Limoges | 87042 | France |
| Novartis Investigative Site | Lyon | 69373 | France |
| Novartis Investigative Site | Montpellier | 34295 | France |
| Novartis Investigative Site | Paris | 75475 | France |
| Novartis Investigative Site | Paris | 75571 | France |
| Novartis Investigative Site | Paris | 75935 | France |
| Novartis Investigative Site | Pierre-Benite Cédex | 69495 | France |
| Novartis Investigative Site | Rennes | 35033 | France |
| Novartis Investigative Site | Rouen | 76038 | France |
| Novartis Investigative Site | Saint-Priest-en-Jarez | 42271 | France |
| Novartis Investigative Site | Strasbourg | 67098 | France |
| Novartis Investigative Site | Toulouse | 31059 | France |
| Novartis Investigative Site | Vandœuvre-lès-Nancy | 54511 | France |
| Novartis Investigative Site | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Novartis Investigative Site | Augsburg | 86156 | Germany |
| Novartis Investigative Site | Berlin | 13125 | Germany |
| Novartis Investigative Site | Cologne | 50937 | Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Düsseldorf | 40225 | Germany |
| Novartis Investigative Site | Erlangen | 91054 | Germany |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Frankfurt | 60590 | Germany |
| Novartis Investigative Site | Freiburg im Breisgau | 79106 | Germany |
| Novartis Investigative Site | Hamburg | 20099 | Germany |
| Novartis Investigative Site | Hamburg | 20246 | Germany |
| Novartis Investigative Site | Jena | 07747 | Germany |
| Novartis Investigative Site | Kiel | 24105 | Germany |
| Novartis Investigative Site | Leipzig | 04103 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | Mannheim | 68167 | Germany |
| Novartis Investigative Site | Münster | 48149 | Germany |
| Novartis Investigative Site | Ulm | Germany |
| Novartis Investigative Site | Würzburg | 97080 | Germany |
| Novartis Investigative Site | Athens | GR | Greece |
| Novartis Investigative Site | Pátrai | GR | 265 00 | Greece |
| Novartis Investigative Site | Thessaloniki | GR | Greece |
| Novartis Investigative Site | Athens | Greece |
| Novartis Investigative Site | Budapest | 1097 | Hungary |
| Novartis Investigative Site | Navi Mumbai | Maharashtra | 410210 | India |
| Novartis Investigative Site | Pune | Maharashtra | 411004 | India |
| Novartis Investigative Site | Delhi | 110 085 | India |
| Novartis Investigative Site | Vellore | 632004 | India |
| Novartis Investigative Site | Haifa | 31096 | Israel |
| Novartis Investigative Site | Jerusalem | 91120 | Israel |
| Novartis Investigative Site | Petah Tikva | 49100 | Israel |
| Novartis Investigative Site | Tel Aviv | 64239 | Israel |
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| Novartis Investigative Site | Milan | MI | 20132 | Italy |
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| Novartis Investigative Site | Ankara | 06100 | Turkey (Türkiye) |
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| Novartis Investigative Site | Glasgow | G51 4TF | United Kingdom |
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| Novartis Investigative Site | Manchester | M13 9WL | United Kingdom |
| Zeiser R, Russo D, Ram R, Hashmi SK, Chakraverty R, Middeke JM, Musso M, Giebel S, Uzay A, Langmuir P, Hamad N, Burock K, Gowda M, Stefanelli T, Lee SJ, Teshima T, Locatelli F. Ruxolitinib in Patients With Corticosteroid-Refractory or Corticosteroid-Dependent Chronic Graft-Versus-Host Disease: 3-Year Final Analysis of the Phase III REACH3 Study. J Clin Oncol. 2025 Aug 10;43(23):2566-2571. doi: 10.1200/JCO-24-02477. Epub 2025 Jun 25. |
| 40472328 | Derived | Mahmoudjafari Z, Kintsch E, Xue Z, Bhatt V, Galvin J, Locatelli F, Zeiser R. Impact of concomitant azoles on ruxolitinib treatment in patients with GVHD: post hoc analyses of REACH2 and REACH3. Blood Adv. 2025 Aug 26;9(16):4206-4216. doi: 10.1182/bloodadvances.2025016212. |
| 35363318 | Derived | Le RQ, Wang X, Zhang H, Li H, Przepiorka D, Vallejo J, Leong R, Ma L, Goldberg KB, Pazdur R, Theoret MR, De Claro A. FDA Approval Summary: Ruxolitinib for Treatment of Chronic Graft-Versus-Host Disease after Failure of One or Two Lines of Systemic Therapy. Oncologist. 2022 Jun 8;27(6):493-500. doi: 10.1093/oncolo/oyac042. |
| 34260836 | Derived | Zeiser R, Polverelli N, Ram R, Hashmi SK, Chakraverty R, Middeke JM, Musso M, Giebel S, Uzay A, Langmuir P, Hollaender N, Gowda M, Stefanelli T, Lee SJ, Teshima T, Locatelli F; REACH3 Investigators. Ruxolitinib for Glucocorticoid-Refractory Chronic Graft-versus-Host Disease. N Engl J Med. 2021 Jul 15;385(3):228-238. doi: 10.1056/NEJMoa2033122. |
| 29316837 | Derived | Jagasia M, Zeiser R, Arbushites M, Delaite P, Gadbaw B, Bubnoff NV. Ruxolitinib for the treatment of patients with steroid-refractory GVHD: an introduction to the REACH trials. Immunotherapy. 2018 Apr;10(5):391-402. doi: 10.2217/imt-2017-0156. Epub 2018 Jan 10. |
| FG002 | Ruxolitinib Cross-Over Period | Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment. |
| COMPLETED |
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| NOT COMPLETED |
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| End of Cross Over Period |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ruxolitinib | Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg). |
| BG001 | Best Available Therapy | Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| ECOG Performance Status | The Eastern Cooperative Oncology Group (ECOG) Performance Score has 6 grades (0-5). 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care. Totally confined to bed/chair. 5 = Death. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit | ORR was defined as the percentage of participants in each arm demonstrating a complete response (CR) or partial response (PR) based on chronic GvHD (cGvHD) disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response. Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies. | Full Analysis Set (FAS): all participants to whom study treatment was assigned by randomization. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020). | Posted | Number | 95% Confidence Interval | percentage of participants | Cycle 7 Day 1 (each cycle was comprised of 4 weeks) |
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| Secondary | Rate of Participants With Clinically Relevant Improvement of the Modified Lee cGvHD Symptom Scale Score | To assess improvement of symptoms based on the total symptom score (TSS); a responder was defined as having achieved a clinically relevant reduction from Baseline of the TSS. The scale consists of 30 items in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological). Participants reported their level of symptom "bother" over the previous month on a 5-point likert scale: not at all, slightly, moderately, quite a bit, or extremely. Subscale scores and the summary score range from 0 to 100, with a higher score indicating worse symptoms. | FAS. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020). | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Cycle 7 Day 1 (each cycle was comprised of 4 weeks) |
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| Secondary | Rate of Failure-free Survival (FFS) | Composite time to event endpoint incorporating the following FFS events: (i) relapse or recurrence of underlying disease or death due to underlying disease, (ii) nonrelapse mortality, or (iii) addition or initiation of another systemic therapy for cGvHD. | FAS. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020). | Posted | Median | 95% Confidence Interval | months | Baseline to when the last participant reached Cycle 7 Day 1 (each cycle was comprised of 4 weeks) |
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| Secondary | Rate of FFS at Study Completion | Composite time to event endpoint incorporating the following FFS events: (i) relapse or recurrence of underlying disease or death due to underlying disease, (ii) nonrelapse mortality, or (iii) addition or initiation of another systemic therapy for cGvHD. | FAS | Posted | Median | 95% Confidence Interval | months | From Baseline to Last Participant Last Visit (LPLV) (approximately 5 years) |
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| Secondary | Best Overall Response (BOR) at Cycle 7 Day 1 | BOR was defined as the percentage of participants who achieved an overall response (CR+PR) based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response at any time point (up to Cycle 7 Day 1 or the start of additional systemic therapy for cGvHD). Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies. This analysis was based on the primary cutoff date (May 2020). | FAS. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020). | Posted | Number | 95% Confidence Interval | percentage of participants | up to Cycle 7 Day 1 (each cycle was comprised of 4 weeks) |
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| Secondary | BOR During Cross-over Treatment With Ruxolitinib | BOR was defined as the percentage of participants who achieved an overall response (CR+PR) based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response at any time point (up to Cycle 7 Day 1 or the start of additional systemic therapy for cGvHD). Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies. | Cross-over Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | from Crossover Cycle 1 Day 1 to any time point up to and including Crossover Cycle 7 Day 1 (each cycle was comprised of 4 weeks) |
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| Secondary | ORR at the End of Cycle 3 | ORR was defined as the percentage of participants in each arm demonstrating a CR or PR based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response. Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies. | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | Cycle 4 Day 1 (each cycle was comprised of 4 weeks) |
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| Secondary | Duration of Response Through Study Completion | DOR was defined as the time from first response until cGvHD progression, death, or the date of change/addition of systemic therapies for cGvHD and as assessed for responders only. Response was based on cGvHD disease assessments (National Institutes of Health consensus criteria). Duration of response was evaluated in participants who achieved a CR or PR at or before Cycle 7 Day 1. The analysis included a larger number of participants than the number of participants who achieved CR or PR at Cycle 7 Day 1 (82 ruxolitinib and 42 BAT) because the analysis took into account not only those participants who achieved CR or PR at Cycle 7 Day 1, but also participants who achieved CR or PR before Cycle 7 Day 1 but who may have lost their response at Cycle 7 Day 1. For this reason, the number of participants in this analysis does not align with the best overall response (BOR) at Cycle 7 Day 1. This analysis was based on the cutoff date upon study completion (December 2022). | FAS. Duration of response was evaluated in participants who achieved a CR or PR at or before Cycle 7 Day 1. | Posted | Median | 95% Confidence Interval | Months | from first response to LPLV (approximately 5 years) |
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| Secondary | Overall Survival (OS) | Overall survival was defined as the time from the date of randomization to the date of death due to any cause. | FAS | Posted | Median | 95% Confidence Interval | months | from the date of randomization to the date of death due to any cause up to LPLV (approximately 5 years) |
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| Secondary | Cumulative Incidence of Non-relapse Mortality (NRM) | Defined as the cumulative incidence rate from competing risk analysis for NRM from the date of randomization to the date of death not preceded by underlying disease relapse/recurrence. | FAS. Only participants with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Months 3, 6, 12, 18, 24, 30, and 36 |
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| Secondary | Percentage of Participants With a ≥ 50% Reduction in Daily Corticosteroid Dose | All corticosteroid dosages prescribed to the participant and all dose changes during the study were to be recorded for assessment of participants with a ≥ 50% reduction in daily corticosteroid dose. | Safety Set: all participants who received at least one dose of study treatment. Participants were to have been analyzed according to the study treatment received, where treatment received was defined as the randomized treatment if the participant took at least one dose of that treatment or the first treatment received if the randomized treatment was never received. Six participants in the BAT arm discontinued before receiving the first dose. Only participants with available data were analyzed. | Posted | Number | percentage of participants | from Day 15 up to Day 182 |
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| Secondary | Percentage of Participants Successfully Tapered Off of All Corticosteroids | All corticosteroid dosages prescribed to the participant and all dose changes during the study were to be recorded for assessment of participants who successfully tapered off of all corticosteroids. Participants who completely tapered off corticosteroids refer to those who permanently discontinued steroids as per the dose administration panel and who did not restart steroids in the same interval. Participants who were tapered off and continued follow-up were also counted as being tapered off with 0 dose in subsequent intervals until they discontinued from the main treatment period or restarted steroid treatment. | FAS. Only participants with available data were analyzed. | Posted | Number | percentage of participants | up to Day 179 |
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| Secondary | Cumulative Incidence of Malignancy Relapse/Recurrence (MR) | Defined as the cumulative incidence rate from competing risk analysis of MR from the date of randomization to hematologic malignancy relapse/recurrence. | FAS. Cumulative incidence was calculated for participants with underlying hematologic malignant disease. Only participants with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Months 3, 6, 12, 18, 24, 30, and 36 |
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| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The FACT-BMT is a 50-item self-report questionnaire that measures the effect of a therapy on domains including physical, functional, social/family, and emotional well-being, together with additional concerns relevant for bone marrow transplantation participants. The questions were based on a 5-point Likert scale, where 0 corresponds to "not at all" and 4 corresponds to "very much." The higher the final score, the better the quality of life. The FACT-BMT total score ranges from 0 to 148. | FAS. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline; up to Cycle 39 Day 1 (each cycle was comprised of 4 weeks) |
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| Secondary | Change From Baseline in EQ-5D-5L | The EQ-5D-5L is a descriptive classification consisting of five dimensions of health: mobility, self-care, usual activities, anxiety/depression, and pain/discomfort. The five-level version (no problems, slight problems, moderate problems, severe problems, and extreme problems) uses a 5-point Likert scale, with 1 being no problems and 5 being extreme problems. | FAS. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline; up to Cycle 39 Day 1 (each cycle was comprised of 4 weeks) |
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| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions that occurred after the participant's signed informed consent was obtained. Abnormal laboratory values or test results occurring after informed consent constituted adverse events only if they induced clinical signs or symptoms, were considered clinically significant, required therapy (e.g., hematologic abnormality that required transfusion or hematological stem cell support), or required changes in study medication(s). TEAEs were defined as those AEs that started or worsened during the on-treatment period (either randomized or cross-over period). | Safety Set. Six participants in the BAT arm discontinued before receiving the first dose. | Posted | Count of Participants | Participants | from Baseline to LPLV (approximately 5 years) |
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| Secondary | Cmax of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses | Cmax was defined as the maximum observed plasma concentration of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule. | Pharmacokinetic Analysis Set (PAS): all participants who provided at least one evaluable pharmacokinetic (PK) concentration. Only participants with available data were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose |
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| Secondary | AUClast of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses | AUClast was defined as the area under the concentration-time curve up to the last measurable concentration of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule. | PAS. Only participants with available data were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hour/mL | Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose |
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| Secondary | AUCinf of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses | AUCinf was defined as the area under the concentration-time curve from time 0 to infinity. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule. | PAS. Only participants with available data were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hour/mL | Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose |
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| Secondary | CL/F of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses | CL/F was defined as the oral dose clearance of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule. | PAS. Only participants with available data were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters/hour | Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose |
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| Secondary | Vz/F of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses | Vz/F was defined as the apparent oral dose volume of distribution of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule. | PAS. Only participants with available data were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose |
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| Secondary | Tmax of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses | tmax was defined as the time to reach the maximum plasma concentration of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule. | PAS. Only participants with available data were analyzed. | Posted | Median | Full Range | hours | Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | t1/2 of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses | t1/2 was defined as the apparent terminal phase disposition half-life of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule. | PAS. Only participants with available data were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Utilization of Medical Resources | The percentage of participants with at least one submission to healthcare encounter was assessed. | Safety Set. Six participants in the BAT arm discontinued before receiving the first dose. | Posted | Number | percentage of participants | from Baseline to LPLV (approximately 5 years) |
|
|
from Baseline to LPLV (approximately 5 years)
Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ruxolitinib | Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg). | 37 | 165 | 86 | 165 | 158 | 165 |
| EG001 | Best Available Therapy | Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision. | 40 | 158 | 71 | 158 | 132 | 158 |
| EG002 | Ruxolitinib Cross-Over Period | Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment. | 10 | 70 | 27 | 70 | 62 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Atypical haemolytic uraemic syndrome | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Spleen disorder | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Splenic haemorrhage | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Angle closure glaucoma | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Corneal erosion | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Corneal perforation | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Gastrointestinal ulcer | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oral dysaesthesia | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Necrosis | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Stenosis | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal wall infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Adenovirus reactivation | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Bacterial translocation | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Dacryocanaliculitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Large intestine infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Lower respiratory tract infection fungal | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Measles | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Meningitis cryptococcal | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Mycobacterial infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumococcal infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pulmonary nocardiosis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory tract infection bacterial | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory tract infection fungal | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Systemic infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Systemic mycosis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Anastomotic complication | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Cytomegalovirus test positive | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Post transplant lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Skin squamous cell carcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Device breakage | Product Issues | MedDRA (25.1) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vulvovaginal inflammation | Reproductive system and breast disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Alveolar proteinosis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Obliterative bronchiolitis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Loss of personal independence in daily activities | Social circumstances | MedDRA (25.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Poor peripheral circulation | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
Clinical Study Agreement
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Incyte Corporation | Call Center | 1.855.463.3463 | medinfo@incyte.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 6, 2020 | Dec 10, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C540383 | ruxolitinib |
| D017893 | Photopheresis |
| D008727 | Methotrexate |
| D009173 | Mycophenolic Acid |
| D019908 | Proto-Oncogene Proteins c-raf |
| D000068338 | Everolimus |
| D020123 | Sirolimus |
| D000069285 | Infliximab |
| D000069283 | Rituximab |
| D015649 | Pentostatin |
| D000068877 | Imatinib Mesylate |
| C551803 | ibrutinib |
| ID | Term |
|---|---|
| D011701 | PUVA Therapy |
| D014467 | Ultraviolet Therapy |
| D010789 | Phototherapy |
| D013812 | Therapeutics |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D048490 | raf Kinases |
| D020930 | MAP Kinase Kinase Kinases |
| D017346 | Protein Serine-Threonine Kinases |
| D011494 | Protein Kinases |
| D017853 | Phosphotransferases (Alcohol Group Acceptor) |
| D010770 | Phosphotransferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011518 | Proto-Oncogene Proteins |
| D015513 | Oncogene Proteins |
| D009363 | Neoplasm Proteins |
| D018942 | Macrolides |
| D007783 | Lactones |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D003070 | Coformycin |
| D005573 | Formycins |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
Not provided
Not provided
| Physician Decision |
|
| Lack of Efficacy |
|
| Adverse Event |
|
| Disease Relapse |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Other |
|
| Unknown |
|
| Not Hispanic/Latino |
|
| Not Reported |
|
| Unknown |
|
| 1 |
|
| 2 |
|
| 3 |
|
| Missing |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| OG002 | Ruxolitinib Cross-Over Period | Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment. |
|
|
|
|
|
|
|
|
|
|