Trial Outcomes & Findings for A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1) (NCT NCT02953678)
NCT ID: NCT02953678
Last Updated: 2021-11-24
Results Overview
Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
From baseline to Day 28
Results posted on
2021-11-24
Participant Flow
This study was conducted at 26 study centers in the United States.
Participant milestones
| Measure |
Ruxolitinib in Combination With Corticosteroids
Participants began oral administration of ruxolitinib at 5 mg twice a day (BID); if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
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|---|---|
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Overall Study
STARTED
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71
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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71
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Reasons for withdrawal
| Measure |
Ruxolitinib in Combination With Corticosteroids
Participants began oral administration of ruxolitinib at 5 mg twice a day (BID); if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
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|---|---|
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Overall Study
Adverse Event
|
20
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|
Overall Study
Death
|
7
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Overall Study
Physician Decision
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23
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|
Overall Study
Progressive Disease of GVHD
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7
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Overall Study
Relapse of Underlying Malignancy
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3
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Overall Study
Withdrawal by participant
|
3
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Overall Study
Includes 2 participants who discontinued ruxolitinib treatment because of clinical improvement
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5
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Overall Study
Participants were transferred to commercial product.
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3
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Baseline Characteristics
Height was not obtained for 5 participants.
Baseline characteristics by cohort
| Measure |
Ruxolitinib in Combination With Corticosteroids
n=71 Participants
Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
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|---|---|
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Age, Continuous
|
52.9 years
STANDARD_DEVIATION 14.18 • n=71 Participants
|
|
Age, Customized
< 65 years
|
58 Participants
n=71 Participants
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Age, Customized
≥ 65 years
|
13 Participants
n=71 Participants
|
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Sex: Female, Male
Female
|
36 Participants
n=71 Participants
|
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Sex: Female, Male
Male
|
35 Participants
n=71 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=71 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=71 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=71 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=71 Participants
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Race (NIH/OMB)
Asian
|
2 Participants
n=71 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=71 Participants
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Race (NIH/OMB)
Black or African American
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3 Participants
n=71 Participants
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Race (NIH/OMB)
White
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66 Participants
n=71 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=71 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=71 Participants
|
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Height
|
170.2 cm
STANDARD_DEVIATION 10.64 • n=66 Participants • Height was not obtained for 5 participants.
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Weight
|
78.64 kg
STANDARD_DEVIATION 21.651 • n=71 Participants
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Body Mass Index (BMI)
|
26.83 kg/m^2
STANDARD_DEVIATION 6.193 • n=66 Participants • Height was not obtained for 5 participants; BMI could not be calculated for these participants.
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Body Surface Area (BSA)
|
1.91 m^2
STANDARD_DEVIATION 0.301 • n=66 Participants • Height was not obtained for 5 participants; BSA could not be calculated for these participants.
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Eastern Cooperative Oncology Group (ECOG) grade at baseline
ECOG - 0
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3 Participants
n=71 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) grade at baseline
ECOG - 1
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24 Participants
n=71 Participants
|
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Eastern Cooperative Oncology Group (ECOG) grade at baseline
ECOG - 2
|
25 Participants
n=71 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) grade at baseline
ECOG - 3
|
17 Participants
n=71 Participants
|
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Eastern Cooperative Oncology Group (ECOG) grade at baseline
ECOG - 4
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1 Participants
n=71 Participants
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|
Eastern Cooperative Oncology Group (ECOG) grade at baseline
ECOG - 5
|
0 Participants
n=71 Participants
|
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Eastern Cooperative Oncology Group (ECOG) grade at baseline
Missing
|
1 Participants
n=71 Participants
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PRIMARY outcome
Timeframe: From baseline to Day 28Population: Efficacy Evaluable Participants who had a CR, VGPR, or PR at Day 28 response assessment or other response assessments within ± 2 days of Day 28, on or before the start of new anti-GVHD therapy
Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).
Outcome measures
| Measure |
Ruxolitinib in Combination With Corticosteroids
n=71 Participants
Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
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|---|---|
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Overall Response Rate (ORR) at Day 28
Responders - CR
|
19 Participants
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Overall Response Rate (ORR) at Day 28
Responders - VGPR
|
7 Participants
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Overall Response Rate (ORR) at Day 28
Responders - PR
|
13 Participants
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SECONDARY outcome
Timeframe: From baseline to days 14, 56, and 100Population: Efficacy Evaluable Population included all participants enrolled in this study.
Defined as the percentage of participants demonstrating a CR, VGPR, or PR.
Outcome measures
| Measure |
Ruxolitinib in Combination With Corticosteroids
n=71 Participants
Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
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|---|---|
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Overall Response Rate (ORR)
Day 14
|
62.0 percentage of participants
Interval 49.7 to 73.2
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Overall Response Rate (ORR)
Day 56
|
36.6 percentage of participants
Interval 25.5 to 48.9
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Overall Response Rate (ORR)
Day 100
|
32.4 percentage of participants
Interval 21.8 to 44.5
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SECONDARY outcome
Timeframe: From baseline to Months 6, 9, 12, and 24Population: Efficacy Evaluable Participants including all responders as of the data cutoff (02 JUL 2018).
Defined as the proportion of subjects who died due to causes other than malignancy relapse.
Outcome measures
| Measure |
Ruxolitinib in Combination With Corticosteroids
n=71 Participants
Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
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|---|---|
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Nonrelapse Mortality (NRM)
6 months
|
44.4 percentage of participants
Interval 32.5 to 55.7
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Nonrelapse Mortality (NRM)
9 months
|
48.2 percentage of participants
Interval 35.8 to 59.5
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Nonrelapse Mortality (NRM)
12 months
|
52.9 percentage of participants
Interval 39.6 to 64.5
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Nonrelapse Mortality (NRM)
24 months
|
64.8 percentage of participants
Interval 46.0 to 78.5
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SECONDARY outcome
Timeframe: From Baseline up to 6 monthsPopulation: Efficacy Evaluable Population included all participants enrolled in this study. Participants who achieved ORR were analyzed for this outcome measure.
Defined as the time from first response until graft-versus-host disease (GVHD) progression or death. DOR was assessed when all participants who were on the study completed the Day 180 visit.
Outcome measures
| Measure |
Ruxolitinib in Combination With Corticosteroids
n=40 Participants
Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
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|---|---|
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Percentage of Participants With Six-month Duration of Response (DOR)
|
68.2 percentage of participants
Interval 49.6 to 81.2
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SECONDARY outcome
Timeframe: From Baseline up to 3 monthsPopulation: Efficacy Evaluable Population included all participants enrolled in this study. Participants who achieved ORR were analyzed for this outcome measure.
Defined as the time from first response until GVHD progression or death. DOR was assessed when all participants who were on the study completed the Day 84 visit.
Outcome measures
| Measure |
Ruxolitinib in Combination With Corticosteroids
n=40 Participants
Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
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|---|---|
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Percentage of Participants With Three-month DOR
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84.5 percentage of participants
Interval 68.7 to 92.7
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SECONDARY outcome
Timeframe: From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)Population: Efficacy Evaluable Population included all participants enrolled in this study.
Defined as the percentage of participants whose underlying malignancy relapsed.
Outcome measures
| Measure |
Ruxolitinib in Combination With Corticosteroids
n=71 Participants
Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
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|---|---|
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Relapse Rate
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7.0 percentage of participants
Interval 2.3 to 15.7
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SECONDARY outcome
Timeframe: From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)Population: Efficacy Evaluable Population included all participants enrolled in this study.
Defined as the percentage of participants whose malignancy relapsed and had a fatal outcome.
Outcome measures
| Measure |
Ruxolitinib in Combination With Corticosteroids
n=71 Participants
Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
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|---|---|
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Relapse-related Mortality Rate
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5.6 percentage of participants
Interval 1.6 to 13.8
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SECONDARY outcome
Timeframe: From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)Population: Efficacy Evaluable Participants
Defined as the time from first dose of ruxolitinib to the earliest date that a participant died, had a relapse/progression of the underlying malignancy, required additional therapy for aGVHD, or demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD).
Outcome measures
| Measure |
Ruxolitinib in Combination With Corticosteroids
n=71 Participants
Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
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|---|---|
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Failure-free Survival (FFS)
|
85.0 days
Interval 42.0 to 158.0
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SECONDARY outcome
Timeframe: From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)Population: Efficacy Evaluable Participants: Participants who had CR, VGPR, or PR on or before the start of new anti-GVHD therapy.
Defined as the time from study enrollment (first day of ruxolitinib treatment) to death due to any cause.
Outcome measures
| Measure |
Ruxolitinib in Combination With Corticosteroids
n=71 Participants
Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
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|---|---|
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Overall Survival (OS)
|
232.0 days
Interval 93.0 to 675.0
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SECONDARY outcome
Timeframe: From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)Population: Safety Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug.
AE was any unfavorable and unintended sign, symptom, or disease temporally associated with use of medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Serious AE was any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. TEAE was an AE that was reported for the first time, or worsening of a pre-existing event after the first dose of study drug (until 30 days after the last dose of study drug). Severity of AEs was described and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03). Grade 3 and above would constitute a severe, life-threatening, or death event.
Outcome measures
| Measure |
Ruxolitinib in Combination With Corticosteroids
n=71 Participants
Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
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|---|---|
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Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEs
TEAEs
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71 Participants
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Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEs
Serious TEAEs
|
59 Participants
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Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEs
Grade 3 or Higher TEAEs
|
69 Participants
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Adverse Events
Ruxolitinib in Combination With Corticosteroids
Serious events: 59 serious events
Other events: 69 other events
Deaths: 46 deaths
Serious adverse events
| Measure |
Ruxolitinib in Combination With Corticosteroids
n=71 participants at risk
Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
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|---|---|
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Blood and lymphatic system disorders
Anaemia
|
2.8%
2/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
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|
Blood and lymphatic system disorders
Thrombocytopenia
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1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
2.8%
2/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Cardiac disorders
Pulseless electrical activity
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Eye disorders
Blindness
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Eye disorders
Eye disorder
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
3/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
2.8%
2/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
2.8%
2/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
2/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
2.8%
2/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
11.3%
8/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
General disorders
Sudden death
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic failure
|
2.8%
2/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Immune system disorders
Acute graft versus host disease
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Immune system disorders
Graft versus host disease in liver
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Candida infection
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Citrobacter infection
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Cystitis
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Device related infection
|
2.8%
2/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Enterococcal infection
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Enterocolitis infectious
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Escherichia urinary tract infection
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Fungaemia
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Hepatic infection fungal
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
2.8%
2/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Klebsiella bacteraemia
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Lung infection
|
7.0%
5/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Mycotic endophthalmitis
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Peritonitis
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
7.0%
5/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia legionella
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
12.7%
9/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
4.2%
3/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Sialoadenitis
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
2.8%
2/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal infection
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal sepsis
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Investigations
Platelet count decreased
|
2.8%
2/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
2.8%
2/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.8%
2/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.8%
2/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
2.8%
2/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
4.2%
3/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
9.9%
7/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
2.8%
2/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Enterocolitis
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
General disorders
Disease progression
|
2.8%
2/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Liver injury
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Enterococcal sepsis
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
1.4%
1/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Ruxolitinib in Combination With Corticosteroids
n=71 participants at risk
Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
63.4%
45/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.5%
6/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.3%
13/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
9.9%
7/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
19.7%
14/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Eye disorders
Dry eye
|
15.5%
11/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Eye disorders
Vision blurred
|
11.3%
8/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
15.5%
11/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
21.1%
15/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
8.5%
6/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
18.3%
13/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.2%
20/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
15.5%
11/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.0%
5/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
7.0%
5/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
15.5%
11/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
9.9%
7/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
14.1%
10/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
32.4%
23/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
7.0%
5/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
22.5%
16/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
11.3%
8/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
31.0%
22/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
General disorders
Malaise
|
8.5%
6/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
9.9%
7/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
General disorders
Oedema
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
46.5%
33/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
15.5%
11/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
7.0%
5/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
BK virus infection
|
7.0%
5/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus infection
|
12.7%
9/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Enterococcal infection
|
8.5%
6/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal infection
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
8.5%
6/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.0%
5/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
19.7%
14/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
25.4%
18/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
23.9%
17/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
12.7%
9/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
15.5%
11/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
18.3%
13/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Investigations
International normalised ratio increased
|
9.9%
7/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
11.3%
8/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
38.0%
27/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Investigations
Platelet count decreased
|
45.1%
32/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
9.9%
7/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Investigations
White blood cell count decreased
|
29.6%
21/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Acidosis
|
8.5%
6/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.5%
16/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.0%
5/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
23.9%
17/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
11.3%
8/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
8.5%
6/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
12.7%
9/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
18.3%
13/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
31.0%
22/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
14.1%
10/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
47.9%
34/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.8%
24/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
18.3%
13/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
26.8%
19/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.3%
13/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.5%
16/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.8%
24/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.0%
5/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.9%
12/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
14.1%
10/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
18.3%
13/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Nervous system disorders
Lethargy
|
7.0%
5/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
8.5%
6/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Nervous system disorders
Tremor
|
9.9%
7/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
14.1%
10/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
12.7%
9/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Delirium
|
8.5%
6/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
15.5%
11/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Hallucination
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
14.1%
10/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
18.3%
13/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
16.9%
12/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Micturition urgency
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
14.1%
10/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
8.5%
6/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.1%
15/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.8%
24/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.3%
8/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.9%
7/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.3%
8/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.7%
9/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.0%
5/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.9%
7/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.5%
6/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.7%
9/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
22.5%
16/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
19.7%
14/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.5%
6/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.6%
4/71 • From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER