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Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial)

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ClinicalTrials.gov Identifier: NCT01243944
Recruitment Status : Completed
First Posted : November 19, 2010
Results First Posted : March 6, 2015
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Incyte Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Polycythemia Vera
Interventions Drug: ruxolitinib tablets
Other: Best Available Therapy (BAT)
Enrollment 222

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ruxolitinib Best Available Therapy
Hide Arm/Group Description Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg once a day (QD) to 25 mg BID based on safety and efficacy Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Period Title: Overall Study
Started 110 111 [1]
Completed 93 [2] 3 [2]
Not Completed 17 108
Reason Not Completed
Adverse Event             4             2
Lack of Efficacy             0             98
Disease progression             5             1
Patient decision             6             5
Physician Decision             2             2
[1]
One subject withdrew consent 5 days after randomization to BAT arm and wasn't treated while on study
[2]
These are the numbers of subjects who completed 48 weeks of treatment.
Arm/Group Title Ruxolitinib Best Available Therapy Total
Hide Arm/Group Description Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements. Total of all reporting groups
Overall Number of Baseline Participants 110 112 222
Hide Baseline Analysis Population Description
All enrolled participants, regardless treated or not.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants 112 participants 222 participants
61.1  (10.48) 59.1  (10.25) 60.1  (10.39)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 110 participants 112 participants 222 participants
< 60 years 49 54 103
≥ 60 years 61 58 119
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 112 participants 222 participants
Female
44
  40.0%
32
  28.6%
76
  34.2%
Male
66
  60.0%
80
  71.4%
146
  65.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 110 participants 112 participants 222 participants
White/Caucasian 98 96 194
Black/African American 1 0 1
Asian 11 16 27
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 110 participants 112 participants 222 participants
76.6  (14.09) 79.0  (17.34) 77.8  (15.83)
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 110 participants 112 participants 222 participants
172.2  (8.44) 173.3  (9.79) 172.8  (9.14)
[1]
Measure Description: Height was missing at study entry for one patient in the ruxolitinib arm.
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 110 participants 112 participants 222 participants
25.8  (3.82) 26.1  (4.24) 25.9  (4.03)
ECOG performance status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 110 participants 112 participants 222 participants
0 76 77 153
1 31 34 65
2 3 1 4
[1]
Measure Description: Eastern Cooperative Oncology Group (ECOG) - ECOG Status: 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2=Ambulatory and capable of all selfcare but unable to carry out any work activities up and about more than 50% of waking hours
1.Primary Outcome
Title The Percentage of Subjects Achieving a Primary Response at Week 32
Hide Description Primary response was defined as having achieved hematocrit control (the absence of phlebotomy eligibility beginning at the Week 8 visit and continuing through Week 32) and Spleen Volume Reduction (a greater than or equal to 35% reduction from baseline in spleen volume at Week 32).
Time Frame 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.
Arm/Group Title Ruxolitinib Best Available Therapy
Hide Arm/Group Description:
Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Overall Number of Participants Analyzed 110 112
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
22.7
(15.3 to 31.7)
0.9
(0.0 to 4.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitinib, Best Available Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Exact Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 32.67
Confidence Interval (2-Sided) 95%
5.04 to 1337
Estimation Comments [Not Specified]
2.Secondary Outcome
Title The Percentage of Subjects Achieving a Durable Primary Response at Week 48
Hide Description Durable Primary Response was defined as any subject who achieved the primary outcome measure and who maintained their response up to 48 weeks after randomization.
Time Frame 48 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.
Arm/Group Title Ruxolitinib Best Available Therapy
Hide Arm/Group Description:
Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Overall Number of Participants Analyzed 110 112
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20.0
(13.0 to 28.7)
0.9
(0.0 to 4.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitinib, Best Available Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Exact Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 28.01
Confidence Interval (2-Sided) 95%
4.24 to 1144
Estimation Comments [Not Specified]
3.Secondary Outcome
Title The Percentage of Subjects Achieving Complete Hematological Remission at Week 32
Hide Description Complete Hematological Remission at Week 32 was defined as any subject who achieved hematocrit control with a platelet count less than or equal to 400 X 10^9/L and a white blood cell count less than or equal to 10 X 10^9/L.
Time Frame 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.
Arm/Group Title Ruxolitinib Best Available Therapy
Hide Arm/Group Description:
Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Overall Number of Participants Analyzed 110 112
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23.6
(16.1 to 32.7)
8.0
(3.7 to 14.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitinib, Best Available Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
Method Exact Cochran-Mantel-Haenszel
Comments P-value was calculated using stratified exact Cochran-Mantel-Haenszel test by adjusting for the WBC/platelet status (abnormal vs normal) at baseline.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.57
Confidence Interval (2-Sided) 95%
1.50 to 9.06
Estimation Comments [Not Specified]
4.Secondary Outcome
Title The Percentage of Subjects Who Achieved a Durable Complete Hematological Remission at Week 48
Hide Description Durable Complete Hematological Remission was defined as any subject who achieved Complete Hematological Remission at Week 32 and maintained their response up to 48 weeks after randomization.
Time Frame 48 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.
Arm/Group Title Ruxolitinib Best Available Therapy
Hide Arm/Group Description:
Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Overall Number of Participants Analyzed 110 112
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20.9
(13.7 to 29.7)
0.9
(0.0 to 4.9)
5.Secondary Outcome
Title The Percentage of Subjects Who Achieved a Durable Hematocrit Control at Week 48
Hide Description Durable Hematocrit Control was defined as any subject who achieved phlebotomy eligibility independence from Week 8 to Week 32 and maintained hematocrit control up to 48 weeks after randomization.
Time Frame 48 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.
Arm/Group Title Ruxolitinib Best Available Therapy
Hide Arm/Group Description:
Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Overall Number of Participants Analyzed 110 112
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54.5
(44.8 to 64.1)
1.8
(0.2 to 6.3)
6.Secondary Outcome
Title The Percentage of Subjects Who Achieved Durable Spleen Volume Reduction at Week 48
Hide Description Durable Spleen Volume Reduction was defined as a subject who achieved at least 35% reduction from baseline in spleen volume at Week 32 and maintained that response 48 weeks after randomization.
Time Frame 48 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.
Arm/Group Title Ruxolitinib Best Available Therapy
Hide Arm/Group Description:
Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Overall Number of Participants Analyzed 110 112
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
37.3
(28.2 to 47.0)
0.9
(0.0 to 4.9)
7.Secondary Outcome
Title Estimated Duration of the Primary Response
Hide Description

Duration of the primary response is defined as the time from the first occurrence when both components of the primary endpoint are met until the date of the first documented disease progression (end of response).

Kaplan-Meier estimates are provided for duration of primary response.

Time Frame Through study completion, analysis was conducted when all patients had completed the Week 80 visit or discontinued the study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization. Duration of response was pre-specified in the protocol to be analyzed for the ruxolitinib arm only considering the study design which allowed crossover for the BAT arm beginning at Week 32.
Arm/Group Title Ruxolitinib
Hide Arm/Group Description:
Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
Overall Number of Participants Analyzed 110
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability
16 weeks
1.00 [1] 
(NA to NA)
32 weeks
1.00 [1] 
(NA to NA)
48 weeks
0.92
(0.72 to 0.98)
64 weeks
0.92
(0.72 to 0.98)
80 weeks
0.92
(0.72 to 0.98)
96 weeks
0.92
(0.72 to 0.98)
112 weeks
0.92
(0.72 to 0.98)
128 weeks
0.92
(0.72 to 0.98)
[1]
A confidence interval cannot be estimated at this time-point because no one had lost response.
8.Secondary Outcome
Title The Percentage of Subjects Who Achieved Overall Clinicohematologic Response at Week 32
Hide Description Overall Clinicohematologic Response is defined as any subject who achieved a complete or partial clinicohematologic response per the European LeukemiaNet modified criteria for response in polycythemia vera (PV). A Complete Response (CR) is defined as: hematocrit control, spleen volume reduction at least 35% from baseline, platelet count less than or equal to 400 x 10(9)/L, and white blood cell count less than or equal to 10 x 10(9)/L. A Partial Response (PR) is defined as hematocrit control or response in all 3 of the other criteria.
Time Frame 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.
Arm/Group Title Ruxolitinib Best Available Therapy
Hide Arm/Group Description:
Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Overall Number of Participants Analyzed 110 112
Measure Type: Number
Unit of Measure: percentage of participants
Complete response rate 8.2 0.9
Partial response rate 54.5 18.8
9.Secondary Outcome
Title The Percentage of Subjects Achieving a Durable Complete or Partial Clinicohematologic Response at Week 48
Hide Description Durable Complete or Partial Clinicohematologic Response was defined as any subject who achieved complete or partial clinicohematologic response per the European LeukemiaNet modified criteria for response in polycythemia vera at Week 32 and maintained that response 48 weeks after randomization.
Time Frame 48 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.
Arm/Group Title Ruxolitinib Best Available Therapy
Hide Arm/Group Description:
Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Overall Number of Participants Analyzed 110 112
Measure Type: Number
Unit of Measure: percentage of participants
Complete response rate 7.3 0.9
Partial response rate 50.9 0.9
10.Secondary Outcome
Title Estimated Duration of the Complete Hematological Remission
Hide Description

Duration of the complete hematological remission is defined as the time from the first occurrence of complete hematological remission until the date of the first documented progression (end of response).

Kaplan-Meier estimates are provided for duration of complete hematological remission.

Time Frame Through study completion, analysis was conducted when all patients had completed the Week 80 visit or discontinued the study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization. Duration of response was pre-specified in the protocol to be analyzed for the ruxolitinib arm only considering the study design which allowed crossover for the BAT arm beginning at Week 32.
Arm/Group Title Ruxolitinib
Hide Arm/Group Description:
Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
Overall Number of Participants Analyzed 110
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability
16 weeks
1.00 [1] 
(NA to NA)
32 weeks
1.00 [1] 
(NA to NA)
48 weeks
0.88
(0.66 to 0.96)
64 weeks
0.79
(0.56 to 0.91)
80 weeks
0.69
(0.45 to 0.84)
96 weeks
0.69
(0.45 to 0.84)
112 weeks
0.69
(0.45 to 0.84)
128 weeks
0.69
(0.45 to 0.84)
144 weeks
0.69
(0.45 to 0.84)
[1]
A confidence interval cannot be estimated at this time-point because no one had lost response.
Time Frame The duration of the study up to Week 32. This time frame defines the comparative phase of the study where the majority of patients remained on their original randomized assignment and exposure between ruxolitinib and best available therapy was similar.
Adverse Event Reporting Description Safety population: All subjects who were enrolled and took at least 1 dose of study medication.
 
Arm/Group Title Ruxolitinib Best Available Therapy
Hide Arm/Group Description Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
All-Cause Mortality
Ruxolitinib Best Available Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ruxolitinib Best Available Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   15/110 (13.64%)   10/111 (9.01%) 
Blood and lymphatic system disorders     
Leukocytosis  1  1/110 (0.91%)  0/111 (0.00%) 
Neutropenia  1  1/110 (0.91%)  0/111 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  0/110 (0.00%)  1/111 (0.90%) 
Cardiac failure congestive  1  1/110 (0.91%)  0/111 (0.00%) 
Acute myocardial infarction  1  0/110 (0.00%)  1/111 (0.90%) 
Tachycardia  1  0/110 (0.00%)  1/111 (0.90%) 
Eye disorders     
Cataract  1  1/110 (0.91%)  0/111 (0.00%) 
Glaucoma  1  1/110 (0.91%)  0/111 (0.00%) 
Retinal detachment  1  1/110 (0.91%)  0/111 (0.00%) 
Gastrointestinal disorders     
Dental necrosis  1  1/110 (0.91%)  0/111 (0.00%) 
General disorders     
Chest pain  1  1/110 (0.91%)  0/111 (0.00%) 
Infections and infestations     
Bronchitis viral  1  1/110 (0.91%)  0/111 (0.00%) 
Diverticulitis  1  1/110 (0.91%)  1/111 (0.90%) 
Pneumonia  1  1/110 (0.91%)  1/111 (0.90%) 
Vulvovaginitis trichomonal  1  1/110 (0.91%)  0/111 (0.00%) 
Cellulitis  1  0/110 (0.00%)  1/111 (0.90%) 
Gastroenteritis  1  0/110 (0.00%)  1/111 (0.90%) 
Injury, poisoning and procedural complications     
Lumbar vertebral fracture  1  1/110 (0.91%)  0/111 (0.00%) 
Post procedural haemorrhage  1  1/110 (0.91%)  0/111 (0.00%) 
Splenic rupture  1  1/110 (0.91%)  0/111 (0.00%) 
Fall  1  0/110 (0.00%)  1/111 (0.90%) 
Subdural haematoma  1  0/110 (0.00%)  1/111 (0.90%) 
Metabolism and nutrition disorders     
Gout  1  0/110 (0.00%)  1/111 (0.90%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  1/110 (0.91%)  0/111 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/110 (0.91%)  0/111 (0.00%) 
Acute leukaemia  1  1/110 (0.91%)  0/111 (0.00%) 
Breast cancer  1  1/110 (0.91%)  0/111 (0.00%) 
Myelofibrosis  1  1/110 (0.91%)  0/111 (0.00%) 
Malignant melanoma  1  0/110 (0.00%)  1/111 (0.90%) 
Nervous system disorders     
Neurological symptom  1  1/110 (0.91%)  0/111 (0.00%) 
Renal and urinary disorders     
Bladder disorder  1  0/110 (0.00%)  1/111 (0.90%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/110 (0.91%)  0/111 (0.00%) 
Pulmonary embolism  1  0/110 (0.00%)  1/111 (0.90%) 
Vascular disorders     
Deep vein thrombosis  1  0/110 (0.00%)  1/111 (0.90%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ruxolitinib Best Available Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   105/110 (95.45%)   104/111 (93.69%) 
Blood and lymphatic system disorders     
Anaemia  1  20/110 (18.18%)  3/111 (2.70%) 
Thrombocytopenia  1  9/110 (8.18%)  12/111 (10.81%) 
Ear and labyrinth disorders     
Tinnitus  1  6/110 (5.45%)  3/111 (2.70%) 
Gastrointestinal disorders     
Diarrhoea  1  16/110 (14.55%)  8/111 (7.21%) 
Abdominal pain  1  10/110 (9.09%)  13/111 (11.71%) 
Constipation  1  9/110 (8.18%)  3/111 (2.70%) 
Nausea  1  7/110 (6.36%)  4/111 (3.60%) 
Abdominal pain upper  1  6/110 (5.45%)  5/111 (4.50%) 
General disorders     
Fatigue  1  16/110 (14.55%)  17/111 (15.32%) 
Asthenia  1  8/110 (7.27%)  12/111 (10.81%) 
Oedema peripheral  1  7/110 (6.36%)  7/111 (6.31%) 
Infections and infestations     
Nasopharyngitis  1  10/110 (9.09%)  9/111 (8.11%) 
Herpes zoster  1  7/110 (6.36%)  0/111 (0.00%) 
Investigations     
Weight increased  1  6/110 (5.45%)  1/111 (0.90%) 
Gamma-glutamyltransferase increased  1  6/110 (5.45%)  3/111 (2.70%) 
Metabolism and nutrition disorders     
Decreased appetite  1  3/110 (2.73%)  6/111 (5.41%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  13/110 (11.82%)  5/111 (4.50%) 
Arthralgia  1  8/110 (7.27%)  7/111 (6.31%) 
Back pain  1  6/110 (5.45%)  4/111 (3.60%) 
Myalgia  1  5/110 (4.55%)  8/111 (7.21%) 
Bone pain  1  3/110 (2.73%)  6/111 (5.41%) 
Nervous system disorders     
Headache  1  18/110 (16.36%)  21/111 (18.92%) 
Dizziness  1  13/110 (11.82%)  11/111 (9.91%) 
Paraesthesia  1  5/110 (4.55%)  7/111 (6.31%) 
Psychiatric disorders     
Insomnia  1  5/110 (4.55%)  6/111 (5.41%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  11/110 (10.00%)  2/111 (1.80%) 
Cough  1  9/110 (8.18%)  6/111 (5.41%) 
Epistaxis  1  7/110 (6.36%)  3/111 (2.70%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  15/110 (13.64%)  25/111 (22.52%) 
Night sweats  1  6/110 (5.45%)  9/111 (8.11%) 
Vascular disorders     
Haematoma  1  6/110 (5.45%)  3/111 (2.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
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
Name/Title: Study Director
Organization: Incyte Corporation
Phone: 855-463-3463
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01243944     History of Changes
Other Study ID Numbers: CINC424B2301
First Submitted: November 17, 2010
First Posted: November 19, 2010
Results First Submitted: December 22, 2014
Results First Posted: March 6, 2015
Last Update Posted: November 29, 2018