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A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02953678
Recruitment Status : Completed
First Posted : November 3, 2016
Results First Posted : August 20, 2019
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Graft-versus-host Disease (GVHD)
Interventions Drug: Ruxolitinib
Drug: Prednisone or methylprednisolone
Enrollment 71
Recruitment Details This study was conducted at 26 study centers in the United States.
Pre-assignment Details  
Arm/Group Title Ruxolitinib in Combination With Corticosteroids
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 71
Completed 0
Not Completed 71
Reason Not Completed
Adverse Event             20
Death             7
Physician Decision             23
Progressive Disease of GVHD             7
Relapse of Underlying Malignancy             3
Withdrawal by participant             3
Includes 2 participants who discontinued ruxolitinib treatment because of clinical improvement             5
Participants were transferred to commercial product.             3
Arm/Group Title Ruxolitinib in Combination With Corticosteroids
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 71
Hide Baseline Analysis Population Description
The efficacy evaluable population included all participants enrolled in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants
52.9  (14.18)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
< 65 years Number Analyzed 71 participants
58
  81.7%
≥ 65 years Number Analyzed 71 participants
13
  18.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
Female
36
  50.7%
Male
35
  49.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
Hispanic or Latino
9
  12.7%
Not Hispanic or Latino
60
  84.5%
Unknown or Not Reported
2
   2.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   2.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   4.2%
White
66
  93.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 66 participants
170.2  (10.64)
[1]
Measure Analysis Population Description: Height was not obtained for 5 participants.
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 71 participants
78.64  (21.651)
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 66 participants
26.83  (6.193)
[1]
Measure Analysis Population Description: Height was not obtained for 5 participants; BMI could not be calculated for these participants.
Body Surface Area (BSA)   [1] 
Mean (Standard Deviation)
Unit of measure:  M^2
Number Analyzed 66 participants
1.91  (0.301)
[1]
Measure Analysis Population Description: Height was not obtained for 5 participants; BSA could not be calculated for these participants.
Eastern Cooperative Oncology Group (ECOG) grade at baseline   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
ECOG - 0 Number Analyzed 71 participants
3
   4.2%
ECOG - 1 Number Analyzed 71 participants
24
  33.8%
ECOG - 2 Number Analyzed 71 participants
25
  35.2%
ECOG - 3 Number Analyzed 71 participants
17
  23.9%
ECOG - 4 Number Analyzed 71 participants
1
   1.4%
ECOG - 5 Number Analyzed 71 participants
0
   0.0%
Missing Number Analyzed 71 participants
1
   1.4%
[1]
Measure Description: ECOG scores are from 0-5: 0 = fully active, able to carry on all predisease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light house work, office work; 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = completely disabled, cannot carry on any self-care, totally confined to bed or chair; and 5 = dead.
1.Primary Outcome
Title Overall Response Rate (ORR) at Day 28
Hide Description Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).
Time Frame From baseline to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Ruxolitinib in Combination With Corticosteroids
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 71
Measure Type: Count of Participants
Unit of Measure: Participants
Responders - CR
19
  26.8%
Responders - VGPR
7
   9.9%
Responders - PR
13
  18.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitinib in Combination With Corticosteroids
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Exact method for binomial distributions
Estimated Value 54.9
Confidence Interval (2-Sided) 95%
42.7 to 66.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description Defined as the percentage of participants demonstrating a CR, VGPR, or PR.
Time Frame From baseline to days 14, 56, and 100
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population included all participants enrolled in this study.
Arm/Group Title Ruxolitinib in Combination With Corticosteroids
Hide Arm/Group Description:
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 up to approximately 27 months. Participants did receive prednisone daily orally (PO) daily or methylprednisolone daily intravenously( IV) as per protocol.
Overall Number of Participants Analyzed 71
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 14
62.0
(49.7 to 73.2)
Day 56
36.6
(25.5 to 48.9)
Day 100
32.4
(21.8 to 44.5)
3.Secondary Outcome
Title Nonrelapse Mortality (NRM)
Hide Description Defined as the proportion of subjects who died due to causes other than malignancy relapse.
Time Frame From baseline to Months 6, 9, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Participants including all responders as of the data cutoff (02 JUL 2018).
Arm/Group Title Ruxolitinib in Combination With Corticosteroids
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 71
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6 months
44.4
(32.5 to 55.7)
9 months
48.2
(35.8 to 59.5)
12 months
52.9
(39.6 to 64.5)
24 months
64.8
(46.0 to 78.5)
4.Secondary Outcome
Title Percentage of Participants With Six-month Duration of Response (DOR)
Hide Description 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.
Time Frame From Baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population included all participants enrolled in this study. Participants who achieved ORR were analyzed for this outcome measure.
Arm/Group Title Ruxolitinib in Combination With Corticosteroids
Hide Arm/Group Description:
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 up to approximately 27 months. Participants did receive prednisone daily orally (PO) daily or methylprednisolone daily intravenously( IV) as per protocol.
Overall Number of Participants Analyzed 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
68.2
(49.6 to 81.2)
5.Secondary Outcome
Title Percentage of Participants With Three-month DOR
Hide Description 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.
Time Frame From Baseline up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population included all participants enrolled in this study. Participants who achieved ORR were analyzed for this outcome measure.
Arm/Group Title Ruxolitinib in Combination With Corticosteroids
Hide Arm/Group Description:
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 up to approximately 27 months. Participants did receive prednisone daily orally (PO) daily or methylprednisolone daily intravenously( IV) as per protocol.
Overall Number of Participants Analyzed 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
84.5
(68.7 to 92.7)
6.Secondary Outcome
Title Relapse Rate
Hide Description Defined as the percentage of participants whose underlying malignancy relapsed.
Time Frame From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population included all participants enrolled in this study.
Arm/Group Title Ruxolitinib in Combination With Corticosteroids
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 71
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7.0
(2.3 to 15.7)
7.Secondary Outcome
Title Relapse-related Mortality Rate
Hide Description Defined as the percentage of participants whose malignancy relapsed and had a fatal outcome.
Time Frame From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population included all participants enrolled in this study.
Arm/Group Title Ruxolitinib in Combination With Corticosteroids
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 71
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.6
(1.6 to 13.8)
8.Secondary Outcome
Title Failure-free Survival (FFS)
Hide Description 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).
Time Frame From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Participants
Arm/Group Title Ruxolitinib in Combination With Corticosteroids
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 71
Median (95% Confidence Interval)
Unit of Measure: days
85.0
(42.0 to 158.0)
9.Secondary Outcome
Title Overall Survival (OS)
Hide Description Defined as the time from study enrollment (first day of ruxolitinib treatment) to death due to any cause.
Time Frame From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Participants: Participants who had CR, VGPR, or PR on or before the start of new anti-GVHD therapy.
Arm/Group Title Ruxolitinib in Combination With Corticosteroids
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 71
Median (95% Confidence Interval)
Unit of Measure: days
232.0
(93.0 to 675.0)
10.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEs
Hide Description 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.
Time Frame From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug.
Arm/Group Title Ruxolitinib in Combination With Corticosteroids
Hide Arm/Group Description:
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 up to approximately 27 months. Participants did receive prednisone daily orally (PO) daily or methylprednisolone daily intravenously( IV) as per protocol.
Overall Number of Participants Analyzed 71
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
71
 100.0%
Serious TEAEs
59
  83.1%
Grade 3 or Higher TEAEs
69
  97.2%
Time Frame From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
Adverse Event Reporting Description The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
 
Arm/Group Title Ruxolitinib in Combination With Corticosteroids
Hide Arm/Group Description 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.
All-Cause Mortality
Ruxolitinib in Combination With Corticosteroids
Affected / at Risk (%)
Total   46/71 (64.79%) 
Hide Serious Adverse Events
Ruxolitinib in Combination With Corticosteroids
Affected / at Risk (%)
Total   59/71 (83.10%) 
Blood and lymphatic system disorders   
Anaemia  1  2/71 (2.82%) 
Thrombocytopenia  1  1/71 (1.41%) 
Cardiac disorders   
Cardiac arrest  1  1/71 (1.41%) 
Myocardial infarction  1  2/71 (2.82%) 
Palpitations  1  1/71 (1.41%) 
Pulseless electrical activity  1  1/71 (1.41%) 
Supraventricular tachycardia  1  1/71 (1.41%) 
Eye disorders   
Blindness  1  1/71 (1.41%) 
Eye disorder  1  1/71 (1.41%) 
Gastrointestinal disorders   
Abdominal pain  1  1/71 (1.41%) 
Abdominal pain upper  1  1/71 (1.41%) 
Diarrhoea  1  3/71 (4.23%) 
Dysphagia  1  1/71 (1.41%) 
Gastritis  1  1/71 (1.41%) 
Gastrointestinal haemorrhage  1  1/71 (1.41%) 
Lower gastrointestinal haemorrhage  1  2/71 (2.82%) 
Nausea  1  2/71 (2.82%) 
Pneumatosis intestinalis  1  4/71 (5.63%) 
Retroperitoneal haematoma  1  1/71 (1.41%) 
Small intestinal haemorrhage  1  1/71 (1.41%) 
Toothache  1  1/71 (1.41%) 
Upper gastrointestinal haemorrhage  1  1/71 (1.41%) 
Vomiting  1  2/71 (2.82%) 
Enterocolitis  1  1/71 (1.41%) 
General disorders   
Multiple organ dysfunction syndrome  1  2/71 (2.82%) 
Pain  1  1/71 (1.41%) 
Pyrexia  1  8/71 (11.27%) 
Sudden death  1  1/71 (1.41%) 
Disease progression  1  2/71 (2.82%) 
Fatigue  1  1/71 (1.41%) 
Influenza like illness  1  1/71 (1.41%) 
Hepatobiliary disorders   
Cholecystitis acute  1  1/71 (1.41%) 
Hepatic failure  1  2/71 (2.82%) 
Venoocclusive liver disease  1  1/71 (1.41%) 
Cholecystitis  1  1/71 (1.41%) 
Liver injury  1  1/71 (1.41%) 
Immune system disorders   
Acute graft versus host disease  1  1/71 (1.41%) 
Graft versus host disease in gastrointestinal tract  1  1/71 (1.41%) 
Graft versus host disease in liver  1  1/71 (1.41%) 
Infections and infestations   
Bacteraemia  1  4/71 (5.63%) 
Bronchopulmonary aspergillosis  1  1/71 (1.41%) 
Candida infection  1  1/71 (1.41%) 
Cellulitis  1  1/71 (1.41%) 
Citrobacter infection  1  1/71 (1.41%) 
Cystitis  1  1/71 (1.41%) 
Cytomegalovirus viraemia  1  1/71 (1.41%) 
Device related infection  1  2/71 (2.82%) 
Enterococcal infection  1  1/71 (1.41%) 
Enterocolitis infectious  1  1/71 (1.41%) 
Escherichia urinary tract infection  1  1/71 (1.41%) 
Fungaemia  1  1/71 (1.41%) 
Hepatic infection fungal  1  1/71 (1.41%) 
Influenza  1  2/71 (2.82%) 
Klebsiella bacteraemia  1  1/71 (1.41%) 
Lung infection  1  5/71 (7.04%) 
Mycotic endophthalmitis  1  1/71 (1.41%) 
Peritonitis  1  1/71 (1.41%) 
Pneumonia  1  5/71 (7.04%) 
Pneumonia bacterial  1  1/71 (1.41%) 
Pneumonia legionella  1  1/71 (1.41%) 
Respiratory syncytial virus infection  1  1/71 (1.41%) 
Sepsis  1  9/71 (12.68%) 
Septic shock  1  3/71 (4.23%) 
Sialoadenitis  1  1/71 (1.41%) 
Sinusitis  1  1/71 (1.41%) 
Staphylococcal bacteraemia  1  2/71 (2.82%) 
Staphylococcal infection  1  1/71 (1.41%) 
Staphylococcal sepsis  1  1/71 (1.41%) 
Urinary tract infection  1  1/71 (1.41%) 
Enterococcal sepsis  1  1/71 (1.41%) 
Upper respiratory tract infection  1  1/71 (1.41%) 
Injury, poisoning and procedural complications   
Fall  1  1/71 (1.41%) 
Hip fracture  1  1/71 (1.41%) 
Road traffic accident  1  1/71 (1.41%) 
Vascular access complication  1  1/71 (1.41%) 
Investigations   
Alanine aminotransferase increased  1  1/71 (1.41%) 
Aspartate aminotransferase increased  1  1/71 (1.41%) 
Neutrophil count decreased  1  1/71 (1.41%) 
Platelet count decreased  1  2/71 (2.82%) 
Metabolism and nutrition disorders   
Failure to thrive  1  2/71 (2.82%) 
Hyperglycaemia  1  1/71 (1.41%) 
Hypokalaemia  1  1/71 (1.41%) 
Hyponatraemia  1  2/71 (2.82%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  1/71 (1.41%) 
Groin pain  1  1/71 (1.41%) 
Muscular weakness  1  2/71 (2.82%) 
Osteonecrosis  1  1/71 (1.41%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acute myeloid leukaemia recurrent  1  1/71 (1.41%) 
Transitional cell carcinoma  1  1/71 (1.41%) 
Nervous system disorders   
Encephalopathy  1  1/71 (1.41%) 
Headache  1  2/71 (2.82%) 
Syncope  1  1/71 (1.41%) 
Psychiatric disorders   
Confusional state  1  1/71 (1.41%) 
Mental status changes  1  3/71 (4.23%) 
Suicidal ideation  1  1/71 (1.41%) 
Renal and urinary disorders   
Acute kidney injury  1  4/71 (5.63%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  1/71 (1.41%) 
Pulmonary haemorrhage  1  1/71 (1.41%) 
Respiratory failure  1  7/71 (9.86%) 
Vascular disorders   
Deep vein thrombosis  1  1/71 (1.41%) 
Hypotension  1  2/71 (2.82%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ruxolitinib in Combination With Corticosteroids
Affected / at Risk (%)
Total   69/71 (97.18%) 
Blood and lymphatic system disorders   
Anaemia  1  45/71 (63.38%) 
Neutropenia  1  6/71 (8.45%) 
Thrombocytopenia  1  13/71 (18.31%) 
Cardiac disorders   
Pericardial effusion  1  7/71 (9.86%) 
Sinus tachycardia  1  14/71 (19.72%) 
Eye disorders   
Dry eye  1  11/71 (15.49%) 
Vision blurred  1  8/71 (11.27%) 
Gastrointestinal disorders   
Abdominal distension  1  11/71 (15.49%) 
Abdominal pain  1  15/71 (21.13%) 
Ascites  1  6/71 (8.45%) 
Constipation  1  13/71 (18.31%) 
Diarrhoea  1  20/71 (28.17%) 
Dry mouth  1  11/71 (15.49%) 
Dyspepsia  1  5/71 (7.04%) 
Dysphagia  1  5/71 (7.04%) 
Flatulence  1  11/71 (15.49%) 
Gastrooesophageal reflux disease  1  4/71 (5.63%) 
Haemorrhoids  1  7/71 (9.86%) 
Lower gastrointestinal haemorrhage  1  10/71 (14.08%) 
Nausea  1  23/71 (32.39%) 
Stomatitis  1  5/71 (7.04%) 
Vomiting  1  16/71 (22.54%) 
General disorders   
Chills  1  8/71 (11.27%) 
Fatigue  1  22/71 (30.99%) 
Malaise  1  6/71 (8.45%) 
Non-cardiac chest pain  1  7/71 (9.86%) 
Oedema  1  4/71 (5.63%) 
Oedema peripheral  1  33/71 (46.48%) 
Pyrexia  1  11/71 (15.49%) 
Pain  1  4/71 (5.63%) 
Immune system disorders   
Hypogammaglobulinaemia  1  5/71 (7.04%) 
Infections and infestations   
BK virus infection  1  5/71 (7.04%) 
Cytomegalovirus infection  1  9/71 (12.68%) 
Cytomegalovirus viraemia  1  4/71 (5.63%) 
Enterococcal infection  1  6/71 (8.45%) 
Staphylococcal infection  1  4/71 (5.63%) 
Urinary tract infection  1  6/71 (8.45%) 
Upper Respiratory Tract Infection  1  6/71 (8.45%) 
Injury, poisoning and procedural complications   
Contusion  1  5/71 (7.04%) 
Fall  1  14/71 (19.72%) 
Investigations   
Alanine aminotransferase increased  1  18/71 (25.35%) 
Aspartate aminotransferase increased  1  17/71 (23.94%) 
Blood alkaline phosphatase increased  1  9/71 (12.68%) 
Blood bilirubin increased  1  11/71 (15.49%) 
Blood creatinine increased  1  13/71 (18.31%) 
International normalised ratio increased  1  7/71 (9.86%) 
Lymphocyte count decreased  1  8/71 (11.27%) 
Neutrophil count decreased  1  27/71 (38.03%) 
Platelet count decreased  1  32/71 (45.07%) 
Weight decreased  1  7/71 (9.86%) 
White blood cell count decreased  1  21/71 (29.58%) 
Metabolism and nutrition disorders   
Acidosis  1  6/71 (8.45%) 
Decreased appetite  1  16/71 (22.54%) 
Dehydration  1  5/71 (7.04%) 
Hyperglycaemia  1  17/71 (23.94%) 
Hyperkalaemia  1  8/71 (11.27%) 
Hypermagnesaemia  1  6/71 (8.45%) 
Hypertriglyceridaemia  1  9/71 (12.68%) 
Hypoalbuminaemia  1  13/71 (18.31%) 
Hypocalcaemia  1  22/71 (30.99%) 
Hypoglycaemia  1  10/71 (14.08%) 
Hypokalaemia  1  34/71 (47.89%) 
Hypomagnesaemia  1  24/71 (33.80%) 
Hyponatraemia  1  13/71 (18.31%) 
Hypophosphataemia  1  19/71 (26.76%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  13/71 (18.31%) 
Back pain  1  16/71 (22.54%) 
Muscular weakness  1  24/71 (33.80%) 
Musculoskeletal pain  1  4/71 (5.63%) 
Myalgia  1  5/71 (7.04%) 
Pain in extremity  1  12/71 (16.90%) 
Nervous system disorders   
Dizziness  1  10/71 (14.08%) 
Dysgeusia  1  4/71 (5.63%) 
Encephalopathy  1  4/71 (5.63%) 
Headache  1  13/71 (18.31%) 
Lethargy  1  5/71 (7.04%) 
Paraesthesia  1  4/71 (5.63%) 
Peripheral sensory neuropathy  1  4/71 (5.63%) 
Somnolence  1  6/71 (8.45%) 
Syncope  1  4/71 (5.63%) 
Tremor  1  7/71 (9.86%) 
Psychiatric disorders   
Anxiety  1  10/71 (14.08%) 
Confusional state  1  9/71 (12.68%) 
Delirium  1  6/71 (8.45%) 
Depression  1  11/71 (15.49%) 
Hallucination  1  4/71 (5.63%) 
Insomnia  1  10/71 (14.08%) 
Renal and urinary disorders   
Acute kidney injury  1  13/71 (18.31%) 
Haematuria  1  12/71 (16.90%) 
Micturition urgency  1  4/71 (5.63%) 
Pollakiuria  1  10/71 (14.08%) 
Urinary incontinence  1  6/71 (8.45%) 
Urinary retention  1  4/71 (5.63%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  15/71 (21.13%) 
Dyspnoea  1  24/71 (33.80%) 
Epistaxis  1  8/71 (11.27%) 
Hiccups  1  4/71 (5.63%) 
Hypoxia  1  7/71 (9.86%) 
Nasal congestion  1  8/71 (11.27%) 
Pleural effusion  1  9/71 (12.68%) 
Productive cough  1  5/71 (7.04%) 
Oropharyngeal pain  1  4/71 (5.63%) 
Skin and subcutaneous tissue disorders   
Dry skin  1  7/71 (9.86%) 
Erythema  1  4/71 (5.63%) 
Pruritus  1  4/71 (5.63%) 
Rash  1  6/71 (8.45%) 
Rash maculo-papular  1  9/71 (12.68%) 
Vascular disorders   
Hypertension  1  16/71 (22.54%) 
Hypotension  1  14/71 (19.72%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Incyte Corporation
Phone: 1-855-463-3463
EMail: medinfo@incyte.com
Layout table for additonal information
Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02953678    
Other Study ID Numbers: INCB 18424-271 (REACH-1)
First Submitted: November 1, 2016
First Posted: November 3, 2016
Results First Submitted: June 24, 2019
Results First Posted: August 20, 2019
Last Update Posted: November 24, 2021