Open Label Ruxolitinib (INCB018424) in Patients With Myelofibrosis and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis
Sponsor
Incyte Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00509899
Collaborator
(none)
154
2
1
116.1
77
0.7
Study Details
Study Description
Brief Summary
To determine the safety, tolerability and effectiveness of ruxolitinib (INCB018424), administered orally to patients with Primary Myelofibrosis (PMF), Post Polycythemia Vera Myelofibrosis (PPV-MF) and Essential Thrombocythemia Myelofibrosis (PET-MF).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Detailed Description
This is a multicenter, open-label, non-randomized, dose escalation study of ruxolitinib, a small molecule Janus kinase (JAK) inhibitor, administered orally to patients with PMF,
PPEV-MF or PET-MF. The study is comprised of 3 parts:
Part 1: Dose escalation and determination of maximum tolerated dose (complete).
Part 2: Exploration of alternative dosing schedules (complete).
Part 3: Further evaluation of selected dose regimens, including additional response measures to explore effect of ruxolitinib on symptoms and other parameters including daily physical activity and long-term survival (ongoing).
Study Design
Study Type:
Interventional
Actual Enrollment
:
154 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2, Open-Label Study of the JAK2 Inhibitor INCB018424 Administered Orally to Patients With Primary Myelofibrosis (PMF) and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis (Post-PV/ET)
Study Start Date
:
Jun 1, 2007
Actual Primary Completion Date
:
Dec 1, 2007
Actual Study Completion Date
:
Feb 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ruxolitinib All participants received oral ruxolitinib. Patients began treatment with either 10 mg twice a day (bid), 15 mg bid, 25 mg bid, 50 mg bid, 25 mg once a day (qd), 50 mg qd, 100 mg qd, or 200 mg qd, depending on the time period when they entered the study. The doses were titrated based on efficacy and safety to a maximum of 25 mg bid for patients who entered the study after sufficient dosing information had been obtained to define the maximum dose for patients in the study. Patients could continue receiving treatment indefinitely if receiving benefit at a dose that continues to maintain benefit but does not exceed a maximum dose of 25 mg BID. |
Drug: Ruxolitinib
5 and 25 mg tablets with a daily dosing range from 10 to 200 mg qd or bid.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Events (AEs) [From Baseline to the interim clinical cut-off date (31 December 2009). The median time on study was 14.8 months, with a range of 26 days to 29.7 months. As of March 1, 2011 the total exposure to ruxolitinib was 269 patient-years.]
Treatment-Emergent AEs are events occurring after first drug administration or worsened from baseline. Treatment-Related AEs are those with a definite, probable, possible or missing causality. A serious AE is a medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is a medical event requiring intervention to prevent 1 of the above. A severe or life-threatening AE is based on intensity, according to National Cancer Institute-Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) v3.0.
- Percentage of Participants With Clinical Improvement (CI) Over Time [Week 12, 24, 36, 48 and 60]
Clinical improvement was defined according to the International Working Group Myelofibrosis Research and Treatment criteria, and required 1 of the following: A ≥ 2 g/dL increase in Hemoglobin level or becoming transfusion independent; Either a ≥ 50% reduction in palpable splenomegaly if spleen was ≥ 10 cm at Baseline or a spleen palpable at > 5 cm at Baseline becomes not palpable; A ≥ 100% increase in platelet count and an absolute platelet count of ≥ 50,000 x 10^9/L or A ≥ 100% increase in absolute neutrophil count (ANC) and an ANC of ≥ 0.5 x 10^9/L.
Secondary Outcome Measures
- Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Spleen Palpation Length Over Time [Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60]
For each visit, patients who had a missing value at the visit, dropped out of the study due to any reasons prior to the visit or had non-palpable spleen at baseline and then became palpable at the time of the visit were all considered as having not achieved the ≥ 50% reduction in spleen palpation length.
- Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume Over Time [Baseline, Weeks 4, 12, 24 and 48]
Spleen volume was assessed in a subgroup of 27 patients using magnetic resonance imaging (MRI) scans (or computed tomography (CT) scans in patients who were not candidates for MRI) of the abdomen in order to allow objective measurement of spleen volume using standard estimation techniques. For each visit, patients who had a missing value at the visit or dropped out of the study due to any reason prior to the visit were considered as not having achieved the ≥35% reduction in spleen volume.
- Change From Baseline in Myelofibrosis Total Symptom Score at Week 24 [Baseline and Week 24]
Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF). Abdominal discomfort, itching, muscle or bone pain, and night sweats are prominent and troubling symptoms in patients with MF. Therefore, the MFSAF-derived responses for these symptoms were analyzed as a total symptom score. Each symptom was assessed on a scale from 0 (absent), 1 (most favorable) to 10 (worst). The total symptom score is a sum of the individual scores and ranges from 0-40. A higher score indicates worse symptoms hence a negative change from baseline indicates improvement.
- Change From Baseline to Week 24 in Health-Related Quality of Life [Baseline and Week 24]
Health-related Quality of Life was assessed using the Global Health Status/Quality of Life Scale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This scale ranges from 0 to 100, with higher scores indicating higher quality of life.
- Change From Baseline in Body Weight Over Time [Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60.]
- Change From Baseline to Week 24 in Eastern Cooperative Oncology Group (ECOG) Performance Status [Baseline and Week 24]
The ECOG performance status measures patients' functional status on the following scale: 0=Fully active, no restrictions; 1=Restricted in physically strenuous activity but ambulatory, able to carry out light work; 2=Ambulatory and capable of all selfcare, unable to carry out any work activities; Up and about > 50% of waking hours; 3=Limited selfcare, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Totally confined to bed or chair; 5=Dead. Data reported indicate the number of participants with a change from Baseline score of -2, -1, 0 and 1.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosed with PMF or Post-PV/ET MF
-
Patients with myelofibrosis requiring therapy
-
Adequate bone marrow reserve
Exclusion Criteria:
- Received anti-cancer medications or investigational therapy in the past 14 days
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rochester | Minnesota | United States | ||
| 2 | Houston | Texas | United States |
Sponsors and Collaborators
- Incyte Corporation
Investigators
- Principal Investigator: Srdan Verstovsek, MD, PhD, M.D. Anderson Cancer Center, Houston, TX
- Principal Investigator: Ayalew Tefferi, MD, Mayo Clinic, Rochester, MN
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT00509899
Other Study ID Numbers:
- INCB 18424-251
First Posted:
Aug 1, 2007
Last Update Posted:
Mar 12, 2018
Last Verified:
Feb 1, 2018
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | This was a non-randomized dose-ranging study. Participants were enrolled into the currently available cohort based on the timeframe when they entered the study. |
| Arm/Group Title | 10 mg Bid | 15 mg Bid | 25 mg Bid | 50 mg Bid | 25 mg qd | 50 mg qd | 100 mg qd | 200 mg qd |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid. | Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid. | Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 25 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 50 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 100 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. |
| Period Title: Overall Study | ||||||||
| STARTED | 30 | 35 | 47 | 5 | 6 | 22 | 6 | 3 |
| COMPLETED | 14 | 26 | 27 | 1 | 1 | 12 | 5 | 2 |
| NOT COMPLETED | 16 | 9 | 20 | 4 | 5 | 10 | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | 10 mg Bid | 15 mg Bid | 25 mg Bid | 50 mg Bid | 25 mg qd | 50 mg qd | 100 mg qd | 200 mg qd | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid. | Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid. | Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 25 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 50 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 100 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Total of all reporting groups |
| Overall Participants | 30 | 35 | 47 | 5 | 6 | 22 | 6 | 3 | 154 |
| Age (years) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [years] |
61.6
(8.29)
|
63.8
(9.57)
|
63.9
(9.06)
|
63.0
(8.37)
|
57.3
(9.89)
|
66.3
(6.66)
|
71.5
(6.89)
|
72.3
(6.43)
|
63.9
(8.86)
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
12
40%
|
12
34.3%
|
16
34%
|
2
40%
|
1
16.7%
|
12
54.5%
|
1
16.7%
|
1
33.3%
|
57
37%
|
| Male |
18
60%
|
23
65.7%
|
31
66%
|
3
60%
|
5
83.3%
|
10
45.5%
|
5
83.3%
|
2
66.7%
|
97
63%
|
| Race/Ethnicity, Customized (Number) [Number] | |||||||||
| Asian |
1
3.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
2
1.3%
|
| Black or African American |
0
0%
|
0
0%
|
1
2.1%
|
0
0%
|
0
0%
|
1
4.5%
|
0
0%
|
0
0%
|
2
1.3%
|
| White |
28
93.3%
|
35
100%
|
45
95.7%
|
5
100%
|
6
100%
|
20
90.9%
|
5
83.3%
|
3
100%
|
147
95.5%
|
| Other |
1
3.3%
|
0
0%
|
1
2.1%
|
0
0%
|
0
0%
|
1
4.5%
|
0
0%
|
0
0%
|
3
1.9%
|
| Disease sub-type (Number) [Number] | |||||||||
| Primary myelofibrosis |
12
40%
|
19
54.3%
|
23
48.9%
|
3
60%
|
5
83.3%
|
14
63.6%
|
5
83.3%
|
0
0%
|
81
52.6%
|
| Post-polycythemia vera-myelofibrosis |
13
43.3%
|
10
28.6%
|
15
31.9%
|
2
40%
|
1
16.7%
|
4
18.2%
|
1
16.7%
|
3
100%
|
49
31.8%
|
| Post-essential thrombocythemia-myelofibrosis |
5
16.7%
|
6
17.1%
|
9
19.1%
|
0
0%
|
0
0%
|
4
18.2%
|
0
0%
|
0
0%
|
24
15.6%
|
| Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [kg/m^2] |
25.8
(3.8)
|
25.3
(4.4)
|
26.2
(5.9)
|
24.8
(2.9)
|
24.7
(2.9)
|
25.3
(4.5)
|
25.8
(6.3)
|
26.3
(3.8)
|
25.7
(4.7)
|
| Palpable spleen length below the costal margin (cm) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [cm] |
19.11
(8.2)
|
18.47
(5.7)
|
17.13
(8.9)
|
13.0
(10.1)
|
19.58
(10.5)
|
20.0
(7.3)
|
20.67
(6.6)
|
18.33
(3.5)
|
18.37
(7.8)
|
| JAK2 V617F mutation status (participants) [Number] | |||||||||
| Negative |
1
3.3%
|
5
14.3%
|
5
10.6%
|
1
20%
|
4
66.7%
|
7
31.8%
|
1
16.7%
|
0
0%
|
24
15.6%
|
| Positive |
22
73.3%
|
29
82.9%
|
39
83%
|
2
40%
|
2
33.3%
|
15
68.2%
|
2
33.3%
|
3
100%
|
114
74%
|
| Unknown |
7
23.3%
|
1
2.9%
|
3
6.4%
|
2
40%
|
0
0%
|
0
0%
|
3
50%
|
0
0%
|
16
10.4%
|
| Eastern Cooperative Oncology Group Performance Status (participants) [Number] | |||||||||
| 0 |
7
23.3%
|
0
0%
|
9
19.1%
|
2
40%
|
1
16.7%
|
5
22.7%
|
1
16.7%
|
0
0%
|
25
16.2%
|
| 1 |
19
63.3%
|
32
91.4%
|
33
70.2%
|
3
60%
|
4
66.7%
|
14
63.6%
|
5
83.3%
|
3
100%
|
113
73.4%
|
| 2 |
4
13.3%
|
3
8.6%
|
5
10.6%
|
0
0%
|
1
16.7%
|
3
13.6%
|
0
0%
|
0
0%
|
16
10.4%
|
Outcome Measures
| Title | Number of Participants With Adverse Events (AEs) |
|---|---|
| Description | Treatment-Emergent AEs are events occurring after first drug administration or worsened from baseline. Treatment-Related AEs are those with a definite, probable, possible or missing causality. A serious AE is a medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is a medical event requiring intervention to prevent 1 of the above. A severe or life-threatening AE is based on intensity, according to National Cancer Institute-Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) v3.0. |
| Time Frame | From Baseline to the interim clinical cut-off date (31 December 2009). The median time on study was 14.8 months, with a range of 26 days to 29.7 months. As of March 1, 2011 the total exposure to ruxolitinib was 269 patient-years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all patients who received at least 1 dose of study medication. |
| Arm/Group Title | 10 mg Bid | 15 mg Bid | 25 mg Bid | 50 mg Bid | All QD |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid. | Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid. | Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups. |
| Measure Participants | 30 | 35 | 47 | 5 | 37 |
| Any Treatment-Emergent Adverse Event |
30
100%
|
35
100%
|
47
100%
|
5
100%
|
37
616.7%
|
| Treatment-Related Adverse Events |
21
70%
|
22
62.9%
|
41
87.2%
|
4
80%
|
29
483.3%
|
| Serious Adverse Events |
8
26.7%
|
17
48.6%
|
21
44.7%
|
2
40%
|
23
383.3%
|
| Severe or Life-threatening Adverse Events |
21
70%
|
25
71.4%
|
39
83%
|
3
60%
|
28
466.7%
|
| Study Drug Interrupted Due to Adverse Events |
9
30%
|
9
25.7%
|
20
42.6%
|
3
60%
|
23
383.3%
|
| Discontinued Study Drug Due to Adverse Events |
6
20%
|
0
0%
|
7
14.9%
|
2
40%
|
5
83.3%
|
| Study Drug Reduced Due to Adverse Events |
8
26.7%
|
12
34.3%
|
26
55.3%
|
1
20%
|
11
183.3%
|
| Title | Percentage of Participants With Clinical Improvement (CI) Over Time |
|---|---|
| Description | Clinical improvement was defined according to the International Working Group Myelofibrosis Research and Treatment criteria, and required 1 of the following: A ≥ 2 g/dL increase in Hemoglobin level or becoming transfusion independent; Either a ≥ 50% reduction in palpable splenomegaly if spleen was ≥ 10 cm at Baseline or a spleen palpable at > 5 cm at Baseline becomes not palpable; A ≥ 100% increase in platelet count and an absolute platelet count of ≥ 50,000 x 10^9/L or A ≥ 100% increase in absolute neutrophil count (ANC) and an ANC of ≥ 0.5 x 10^9/L. |
| Time Frame | Week 12, 24, 36, 48 and 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The intent-to-treat population included all patients who received at least 1 dose of study medication and had at least 1 follow-up assessment for safety and efficacy. N = the number of patients who had clinical response assessed during the time interval. |
| Arm/Group Title | 10 mg Bid | 15 mg Bid | 25 mg Bid | 50 mg Bid | All QD |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid. | Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid. | Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups. |
| Measure Participants | 25 | 34 | 42 | 5 | 32 |
| 12 Weeks [N=25, 34, 42, 5, 32] |
36.0
120%
|
38.2
109.1%
|
38.1
81.1%
|
40.0
800%
|
34.4
573.3%
|
| 24 Weeks [N=21, 31, 40, 4, 29] |
42.9
143%
|
51.6
147.4%
|
37.5
79.8%
|
75.0
1500%
|
37.9
631.7%
|
| 36 Weeks [N=18, 30, 36, 4, 25] |
66.7
222.3%
|
56.7
162%
|
38.9
82.8%
|
50.0
1000%
|
56.0
933.3%
|
| 48 Weeks [N=17, 28, 36, 3, 23] |
47.1
157%
|
67.9
194%
|
41.7
88.7%
|
33.3
666%
|
56.5
941.7%
|
| 60 Weeks [N=15, 21, 33, 2, 21] |
53.3
177.7%
|
66.7
190.6%
|
54.5
116%
|
50.0
1000%
|
61.9
1031.7%
|
| Title | Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Spleen Palpation Length Over Time |
|---|---|
| Description | For each visit, patients who had a missing value at the visit, dropped out of the study due to any reasons prior to the visit or had non-palpable spleen at baseline and then became palpable at the time of the visit were all considered as having not achieved the ≥ 50% reduction in spleen palpation length. |
| Time Frame | Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat population. A total of 16 patients had either a splenectomy prior to study entry, missing Baseline spleen values or had spleen lengths reported as 0 cm and were excluded. |
| Arm/Group Title | 10 mg Bid | 15 mg Bid | 25 mg Bid | 50 mg Bid | All QD |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid. | Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid. | Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups. |
| Measure Participants | 27 | 34 | 37 | 4 | 36 |
| Week 4 [N=27, 34, 37, 4, 36] |
33.3
111%
|
38.2
109.1%
|
43.2
91.9%
|
75.0
1500%
|
30.6
510%
|
| Week 8 [N=27, 34, 37, 4, 36] |
29.6
98.7%
|
50.0
142.9%
|
43.2
91.9%
|
75.0
1500%
|
30.6
510%
|
| Week 12 [N=27, 34, 37, 4, 36] |
33.3
111%
|
47.1
134.6%
|
54.1
115.1%
|
75.0
1500%
|
33.3
555%
|
| Week 24 [N=26, 34, 37, 4, 36] |
34.6
115.3%
|
52.9
151.1%
|
48.6
103.4%
|
50.0
1000%
|
36.1
601.7%
|
| Week 36 [N=26, 34, 37, 4, 36] |
30.8
102.7%
|
47.1
134.6%
|
43.2
91.9%
|
50.0
1000%
|
36.1
601.7%
|
| Week 48 [N=26, 33, 37, 4, 36] |
23.1
77%
|
54.5
155.7%
|
40.5
86.2%
|
25.0
500%
|
27.8
463.3%
|
| Week 60 [N=25, 27, 37, 4, 36] |
20.0
66.7%
|
51.9
148.3%
|
43.2
91.9%
|
25.0
500%
|
25.0
416.7%
|
| Title | Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume Over Time |
|---|---|
| Description | Spleen volume was assessed in a subgroup of 27 patients using magnetic resonance imaging (MRI) scans (or computed tomography (CT) scans in patients who were not candidates for MRI) of the abdomen in order to allow objective measurement of spleen volume using standard estimation techniques. For each visit, patients who had a missing value at the visit or dropped out of the study due to any reason prior to the visit were considered as not having achieved the ≥35% reduction in spleen volume. |
| Time Frame | Baseline, Weeks 4, 12, 24 and 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients with at least 1 Spleen-Volume Measurement. Patients who had not reached the visit were excluded from the analysis. In addition, at Week 48, 5 patients who did not have MRI measurement due to a protocol amendment were considered as not evaluable and were excluded from the analysis. |
| Arm/Group Title | 10 mg Bid | 15 mg Bid |
|---|---|---|
| Arm/Group Description | Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid. | Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid. |
| Measure Participants | 2 | 25 |
| Week 4 [N= 2, 25] |
0.0
0%
|
44.0
125.7%
|
| Week 12 [N= 2, 25] |
0.0
0%
|
48.0
137.1%
|
| Week 24 [N= 2, 25] |
0.0
0%
|
44.0
125.7%
|
| Week 48 [N= 2, 20] |
0.0
0%
|
40.0
114.3%
|
| Title | Change From Baseline in Myelofibrosis Total Symptom Score at Week 24 |
|---|---|
| Description | Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF). Abdominal discomfort, itching, muscle or bone pain, and night sweats are prominent and troubling symptoms in patients with MF. Therefore, the MFSAF-derived responses for these symptoms were analyzed as a total symptom score. Each symptom was assessed on a scale from 0 (absent), 1 (most favorable) to 10 (worst). The total symptom score is a sum of the individual scores and ranges from 0-40. A higher score indicates worse symptoms hence a negative change from baseline indicates improvement. |
| Time Frame | Baseline and Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population for whom data was available. The MFSAF was implemented by protocol amendment while the study was ongoing. Hence data are available for only approximately 50% of enrolled patients. This analysis includes patients with a Baseline total symptom score ≥ 0; 8 patients were excluded because they had a Baseline score = 0. |
| Arm/Group Title | 10 mg Bid | 15 mg Bid | 25 mg Bid | All QD |
|---|---|---|---|---|
| Arm/Group Description | Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid. | Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid. | Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups. |
| Measure Participants | 9 | 26 | 11 | 17 |
| Mean (Standard Deviation) [scores on a scale] |
-4.7
(5.89)
|
-5.6
(7.82)
|
0.9
(8.37)
|
-6.5
(6.38)
|
| Title | Change From Baseline to Week 24 in Health-Related Quality of Life |
|---|---|
| Description | Health-related Quality of Life was assessed using the Global Health Status/Quality of Life Scale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This scale ranges from 0 to 100, with higher scores indicating higher quality of life. |
| Time Frame | Baseline and Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety population included all subjects who received at least 1 dose of study medication, and for whom data was available at both time points. The EORTC QLQ C30 was implemented by protocol amendment and as a result this data are available for only approximately 50% of the enrolled patients. |
| Arm/Group Title | 10 mg Bid | 15 mg Bid | 25 mg Bid | All QD |
|---|---|---|---|---|
| Arm/Group Description | Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid. | Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid. | Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups. |
| Measure Participants | 9 | 28 | 13 | 20 |
| Mean (Standard Deviation) [units on a scale] |
14.81
(21.968)
|
12.80
(22.620)
|
0.63
(20.254)
|
9.16
(28.725)
|
| Title | Change From Baseline in Body Weight Over Time |
|---|---|
| Description | |
| Time Frame | Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population for patients who had reached each time point and for whom data was available. |
| Arm/Group Title | All Participants |
|---|---|
| Arm/Group Description | All participants received ruxolitinib at varying initial dose and regimen. Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. |
| Measure Participants | 146 |
| Week 4 [n=139] |
0.30
(2.656)
|
| Week 8 [n=137] |
1.59
(2.773)
|
| Week 12 [n=129] |
2.44
(3.596)
|
| Week 24 [n=115] |
4.44
(4.422)
|
| Week 36 [n=104] |
5.58
(4.790)
|
| Week 48 [n=99] |
6.35
(5.845)
|
| Week 60 [n=83] |
6.60
(5.451)
|
| Title | Change From Baseline to Week 24 in Eastern Cooperative Oncology Group (ECOG) Performance Status |
|---|---|
| Description | The ECOG performance status measures patients' functional status on the following scale: 0=Fully active, no restrictions; 1=Restricted in physically strenuous activity but ambulatory, able to carry out light work; 2=Ambulatory and capable of all selfcare, unable to carry out any work activities; Up and about > 50% of waking hours; 3=Limited selfcare, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Totally confined to bed or chair; 5=Dead. Data reported indicate the number of participants with a change from Baseline score of -2, -1, 0 and 1. |
| Time Frame | Baseline and Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population for patients who had reached each time point and for whom data was available. |
| Arm/Group Title | 10 mg Bid | 15 mg Bid | 25 mg Bid | 50 mg Bid | All QD |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid. | Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid. | Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups. |
| Measure Participants | 20 | 31 | 39 | 4 | 29 |
| Change from Baseline of -2 |
1
3.3%
|
0
0%
|
1
2.1%
|
0
0%
|
0
0%
|
| Change from Baseline of -1 |
4
13.3%
|
15
42.9%
|
16
34%
|
2
40%
|
15
250%
|
| Change from Baseline of 0 |
12
40%
|
16
45.7%
|
18
38.3%
|
1
20%
|
11
183.3%
|
| Change from Baseline of 1 |
3
10%
|
0
0%
|
4
8.5%
|
1
20%
|
3
50%
|
Adverse Events
| Time Frame | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | 10 mg Bid | 15 mg Bid | 25 mg Bid | 50 mg Bid | All QD | |||||
| Arm/Group Description | Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid. | Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid. | Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. | Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups. | |||||
All Cause Mortality |
||||||||||
| 10 mg Bid | 15 mg Bid | 25 mg Bid | 50 mg Bid | All QD | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| 10 mg Bid | 15 mg Bid | 25 mg Bid | 50 mg Bid | All QD | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/30 (26.7%) | 17/35 (48.6%) | 21/47 (44.7%) | 2/5 (40%) | 23/37 (62.2%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 1/5 (20%) | 3/37 (8.1%) | |||||
| Bone marrow failure | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Extramedullary haemopoiesis | 1/30 (3.3%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Febrile neutropenia | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Splenomegaly | 1/30 (3.3%) | 3/35 (8.6%) | 2/47 (4.3%) | 0/5 (0%) | 0/37 (0%) | |||||
| Cardiac disorders | ||||||||||
| Atrial tachycardia | 1/30 (3.3%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Atrioventricular block | 1/30 (3.3%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Cardiac arrest | 1/30 (3.3%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Cardiac failure | 1/30 (3.3%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Cardiac failure congestive | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Coronary artery disease | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Myocardial infarction | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Myocardial ischaemia | 0/30 (0%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Pericarditis | 1/30 (3.3%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal pain | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Diarrhoea | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Gastrointestinal haemorrhage | 1/30 (3.3%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Odynophagia | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Pancreatic mass | 0/30 (0%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Upper gastrointestinal haemorrhage | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Vomiting | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| General disorders | ||||||||||
| Asthenia | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Chest pain | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Disease progression | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| General symptom | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Hyperpyrexia | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Multi-organ failure | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Non-cardiac chest pain | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Pyrexia | 0/30 (0%) | 0/35 (0%) | 3/47 (6.4%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Systemic inflammatory response syndrome | 0/30 (0%) | 1/35 (2.9%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Hepatobiliary disorders | ||||||||||
| Cholestasis | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Hyperbilirubinaemia | 0/30 (0%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Portal vein thrombosis | 0/30 (0%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Infections and infestations | ||||||||||
| Appendicitis | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Bronchitis | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Cellulitis | 0/30 (0%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Clostridium difficile colitis | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Diverticulitis | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Herpes zoster | 0/30 (0%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Infection | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Lung infection | 0/30 (0%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Pharyngitis | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Pharyngotonsillitis | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Pneumocystis jiroveci pneumonia | 0/30 (0%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Pneumonia | 2/30 (6.7%) | 0/35 (0%) | 3/47 (6.4%) | 1/5 (20%) | 5/37 (13.5%) | |||||
| Pseudomembranous colitis | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Sepsis | 0/30 (0%) | 0/35 (0%) | 2/47 (4.3%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Septic shock | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Sinusitis | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Urinary tract infection | 0/30 (0%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Patella fracture | 0/30 (0%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Spinal compression fracture | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Splenic rupture | 0/30 (0%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Investigations | ||||||||||
| Haemoglobin decreased | 0/30 (0%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Hyperkalaemia | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthralgia | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Gouty arthritis | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Myalgia | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Pain in extremity | 1/30 (3.3%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Spinal column stenosis | 0/30 (0%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Acute myeloid leukaemia | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| B-cell lymphoma | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Breast cancer | 0/30 (0%) | 1/35 (2.9%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Chronic myelomonocytic leukaemia | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Hairy cell leukaemia | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Nervous system disorders | ||||||||||
| Carotid artery stenosis | 0/30 (0%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Carpal tunnel syndrome | 0/30 (0%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Cerebral haemorrhage | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Nerve compression | 0/30 (0%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Post herpetic neuralgia | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Syncope | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Anxiety | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Depression | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Insomnia | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Mental status changes | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Mood altered | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Hydronephrosis | 0/30 (0%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Renal pain | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Reproductive system and breast disorders | ||||||||||
| Benign prostatic hyperplasia | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Ovarian cyst ruptured | 0/30 (0%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Prostatic haemorrhage | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Scrotal pain | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Epistaxis | 0/30 (0%) | 0/35 (0%) | 2/47 (4.3%) | 0/5 (0%) | 0/37 (0%) | |||||
| Obstructive airways disorder | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Orthopnoea | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Pneumonitis | 1/30 (3.3%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Respiratory failure | 1/30 (3.3%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Angioedema | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Vascular disorders | ||||||||||
| Haematoma | 0/30 (0%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Hypotension | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| 10 mg Bid | 15 mg Bid | 25 mg Bid | 50 mg Bid | All QD | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 29/30 (96.7%) | 35/35 (100%) | 47/47 (100%) | 5/5 (100%) | 36/37 (97.3%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 14/30 (46.7%) | 14/35 (40%) | 27/47 (57.4%) | 0/5 (0%) | 18/37 (48.6%) | |||||
| Thrombocytopenia | 12/30 (40%) | 11/35 (31.4%) | 29/47 (61.7%) | 4/5 (80%) | 14/37 (37.8%) | |||||
| Lymphadenopathy | 1/30 (3.3%) | 2/35 (5.7%) | 2/47 (4.3%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Neutropenia | 1/30 (3.3%) | 2/35 (5.7%) | 0/47 (0%) | 1/5 (20%) | 1/37 (2.7%) | |||||
| Coagulopathy | 0/30 (0%) | 2/35 (5.7%) | 1/47 (2.1%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Pancytopenia | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 1/5 (20%) | 1/37 (2.7%) | |||||
| Iron deficiency anaemia | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 1/5 (20%) | 0/37 (0%) | |||||
| Thrombocythaemia | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 1/5 (20%) | 0/37 (0%) | |||||
| Cardiac disorders | ||||||||||
| Extrasystoles | 2/30 (6.7%) | 1/35 (2.9%) | 1/47 (2.1%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Bradycardia | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 1/5 (20%) | 2/37 (5.4%) | |||||
| Palpitations | 2/30 (6.7%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Ear and labyrinth disorders | ||||||||||
| Vertigo | 1/30 (3.3%) | 2/35 (5.7%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Diarrhoea | 8/30 (26.7%) | 12/35 (34.3%) | 15/47 (31.9%) | 1/5 (20%) | 6/37 (16.2%) | |||||
| Nausea | 7/30 (23.3%) | 4/35 (11.4%) | 6/47 (12.8%) | 1/5 (20%) | 6/37 (16.2%) | |||||
| Vomiting | 4/30 (13.3%) | 4/35 (11.4%) | 6/47 (12.8%) | 0/5 (0%) | 5/37 (13.5%) | |||||
| Abdominal pain | 5/30 (16.7%) | 6/35 (17.1%) | 5/47 (10.6%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Abdominal distension | 1/30 (3.3%) | 4/35 (11.4%) | 4/47 (8.5%) | 1/5 (20%) | 3/37 (8.1%) | |||||
| Constipation | 3/30 (10%) | 5/35 (14.3%) | 4/47 (8.5%) | 0/5 (0%) | 0/37 (0%) | |||||
| Dyspepsia | 0/30 (0%) | 1/35 (2.9%) | 5/47 (10.6%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Flatulence | 0/30 (0%) | 4/35 (11.4%) | 1/47 (2.1%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Abdominal pain upper | 1/30 (3.3%) | 2/35 (5.7%) | 1/47 (2.1%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Abdominal discomfort | 1/30 (3.3%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Ascites | 2/30 (6.7%) | 1/35 (2.9%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Haemorrhoids | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 1/5 (20%) | 1/37 (2.7%) | |||||
| Epigastric discomfort | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 1/5 (20%) | 0/37 (0%) | |||||
| Glossodynia | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 1/5 (20%) | 0/37 (0%) | |||||
| General disorders | ||||||||||
| Fatigue | 7/30 (23.3%) | 10/35 (28.6%) | 11/47 (23.4%) | 1/5 (20%) | 7/37 (18.9%) | |||||
| Edema peripheral | 2/30 (6.7%) | 8/35 (22.9%) | 10/47 (21.3%) | 3/5 (60%) | 0/37 (0%) | |||||
| Pyrexia | 1/30 (3.3%) | 4/35 (11.4%) | 6/47 (12.8%) | 2/5 (40%) | 5/37 (13.5%) | |||||
| Oedema | 2/30 (6.7%) | 1/35 (2.9%) | 5/47 (10.6%) | 0/5 (0%) | 0/37 (0%) | |||||
| Chills | 1/30 (3.3%) | 2/35 (5.7%) | 2/47 (4.3%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Non-cardiac chest pain | 0/30 (0%) | 1/35 (2.9%) | 1/47 (2.1%) | 0/5 (0%) | 4/37 (10.8%) | |||||
| Pitting oedema | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Hepatobiliary disorders | ||||||||||
| Hepatomegaly | 1/30 (3.3%) | 1/35 (2.9%) | 3/47 (6.4%) | 1/5 (20%) | 3/37 (8.1%) | |||||
| Caput medusae | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 1/5 (20%) | 0/37 (0%) | |||||
| Infections and infestations | ||||||||||
| Upper respiratory tract infection | 2/30 (6.7%) | 4/35 (11.4%) | 5/47 (10.6%) | 1/5 (20%) | 5/37 (13.5%) | |||||
| Pneumonia | 0/30 (0%) | 3/35 (8.6%) | 4/47 (8.5%) | 0/5 (0%) | 6/37 (16.2%) | |||||
| Urinary tract infection | 3/30 (10%) | 2/35 (5.7%) | 4/47 (8.5%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Bronchitis | 2/30 (6.7%) | 3/35 (8.6%) | 3/47 (6.4%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Herpes zoster | 4/30 (13.3%) | 0/35 (0%) | 5/47 (10.6%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Nasopharyngitis | 3/30 (10%) | 0/35 (0%) | 4/47 (8.5%) | 2/5 (40%) | 1/37 (2.7%) | |||||
| Sinusitis | 0/30 (0%) | 2/35 (5.7%) | 4/47 (8.5%) | 0/5 (0%) | 4/37 (10.8%) | |||||
| Influenza | 1/30 (3.3%) | 3/35 (8.6%) | 2/47 (4.3%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Folliculitis | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 1/5 (20%) | 1/37 (2.7%) | |||||
| Tinea pedis | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 1/5 (20%) | 0/37 (0%) | |||||
| Tinea versicolour | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 1/5 (20%) | 0/37 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Contusion | 3/30 (10%) | 4/35 (11.4%) | 4/47 (8.5%) | 0/5 (0%) | 6/37 (16.2%) | |||||
| Excoriation | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 1/5 (20%) | 0/37 (0%) | |||||
| Limb injury | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 1/5 (20%) | 0/37 (0%) | |||||
| Investigations | ||||||||||
| Cardiac murmur | 6/30 (20%) | 7/35 (20%) | 7/47 (14.9%) | 0/5 (0%) | 7/37 (18.9%) | |||||
| Weight increased | 3/30 (10%) | 4/35 (11.4%) | 9/47 (19.1%) | 1/5 (20%) | 8/37 (21.6%) | |||||
| Electrocardiogram QT prolonged | 0/30 (0%) | 0/35 (0%) | 4/47 (8.5%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Haemoglobin decreased | 1/30 (3.3%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 3/37 (8.1%) | |||||
| Weight decreased | 2/30 (6.7%) | 1/35 (2.9%) | 0/47 (0%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Neutrophil count decreased | 1/30 (3.3%) | 1/35 (2.9%) | 1/47 (2.1%) | 1/5 (20%) | 0/37 (0%) | |||||
| Gamma-glutamyltransferase increased | 0/30 (0%) | 2/35 (5.7%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Arterial bruit | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 1/5 (20%) | 1/37 (2.7%) | |||||
| Troponin increased | 0/30 (0%) | 2/35 (5.7%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Blood pressure increased | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 1/5 (20%) | 0/37 (0%) | |||||
| Body temperature increased | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 1/5 (20%) | 0/37 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Hyperuricaemia | 1/30 (3.3%) | 2/35 (5.7%) | 7/47 (14.9%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Dehydration | 0/30 (0%) | 2/35 (5.7%) | 3/47 (6.4%) | 0/5 (0%) | 0/37 (0%) | |||||
| Hyperglycaemia | 1/30 (3.3%) | 2/35 (5.7%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Hypertriglyceridaemia | 0/30 (0%) | 3/35 (8.6%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Hypokalaemia | 1/30 (3.3%) | 0/35 (0%) | 3/47 (6.4%) | 0/5 (0%) | 0/37 (0%) | |||||
| Iron overload | 2/30 (6.7%) | 0/35 (0%) | 2/47 (4.3%) | 0/5 (0%) | 0/37 (0%) | |||||
| Anorexia | 1/30 (3.3%) | 0/35 (0%) | 2/47 (4.3%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Pain in extremity | 3/30 (10%) | 4/35 (11.4%) | 11/47 (23.4%) | 1/5 (20%) | 5/37 (13.5%) | |||||
| Arthralgia | 2/30 (6.7%) | 8/35 (22.9%) | 5/47 (10.6%) | 2/5 (40%) | 5/37 (13.5%) | |||||
| Back pain | 2/30 (6.7%) | 4/35 (11.4%) | 6/47 (12.8%) | 0/5 (0%) | 3/37 (8.1%) | |||||
| Muscle spasms | 4/30 (13.3%) | 3/35 (8.6%) | 4/47 (8.5%) | 0/5 (0%) | 3/37 (8.1%) | |||||
| Bone pain | 2/30 (6.7%) | 2/35 (5.7%) | 4/47 (8.5%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Musculoskeletal pain | 1/30 (3.3%) | 2/35 (5.7%) | 4/47 (8.5%) | 1/5 (20%) | 1/37 (2.7%) | |||||
| Muscular weakness | 3/30 (10%) | 1/35 (2.9%) | 3/47 (6.4%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Myalgia | 3/30 (10%) | 2/35 (5.7%) | 1/47 (2.1%) | 1/5 (20%) | 1/37 (2.7%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Basal cell carcinoma | 0/30 (0%) | 0/35 (0%) | 4/47 (8.5%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Squamous cell carcinoma | 0/30 (0%) | 0/35 (0%) | 2/47 (4.3%) | 1/5 (20%) | 1/37 (2.7%) | |||||
| Dysplastic naevus syndrome | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 1/5 (20%) | 0/37 (0%) | |||||
| Fibrous histiocytoma | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 1/5 (20%) | 0/37 (0%) | |||||
| Seborrhoeic keratosis | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 1/5 (20%) | 0/37 (0%) | |||||
| Nervous system disorders | ||||||||||
| Headache | 6/30 (20%) | 6/35 (17.1%) | 5/47 (10.6%) | 3/5 (60%) | 6/37 (16.2%) | |||||
| Dizziness | 2/30 (6.7%) | 3/35 (8.6%) | 3/47 (6.4%) | 0/5 (0%) | 5/37 (13.5%) | |||||
| Neuropathy peripheral | 2/30 (6.7%) | 1/35 (2.9%) | 2/47 (4.3%) | 1/5 (20%) | 1/37 (2.7%) | |||||
| Memory impairment | 0/30 (0%) | 2/35 (5.7%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Lethargy | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Psychiatric disorders | ||||||||||
| Insomnia | 2/30 (6.7%) | 4/35 (11.4%) | 3/47 (6.4%) | 0/5 (0%) | 6/37 (16.2%) | |||||
| Depression | 2/30 (6.7%) | 1/35 (2.9%) | 4/47 (8.5%) | 1/5 (20%) | 1/37 (2.7%) | |||||
| Anxiety | 1/30 (3.3%) | 0/35 (0%) | 3/47 (6.4%) | 1/5 (20%) | 2/37 (5.4%) | |||||
| Agitation | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Mental status changes | 1/30 (3.3%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Renal and urinary disorders | ||||||||||
| Pollakiuria | 1/30 (3.3%) | 3/35 (8.6%) | 2/47 (4.3%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Renal failure acute | 0/30 (0%) | 2/35 (5.7%) | 3/47 (6.4%) | 0/5 (0%) | 0/37 (0%) | |||||
| Nephrolithiasis | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 1/5 (20%) | 0/37 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Cough | 2/30 (6.7%) | 7/35 (20%) | 9/47 (19.1%) | 1/5 (20%) | 4/37 (10.8%) | |||||
| Dyspnoea | 2/30 (6.7%) | 4/35 (11.4%) | 7/47 (14.9%) | 0/5 (0%) | 10/37 (27%) | |||||
| Epistaxis | 3/30 (10%) | 0/35 (0%) | 5/47 (10.6%) | 1/5 (20%) | 2/37 (5.4%) | |||||
| Oropharyngeal pain | 3/30 (10%) | 1/35 (2.9%) | 2/47 (4.3%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Pleural effusion | 1/30 (3.3%) | 1/35 (2.9%) | 3/47 (6.4%) | 0/5 (0%) | 0/37 (0%) | |||||
| Nasal congestion | 0/30 (0%) | 0/35 (0%) | 3/47 (6.4%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Dysphonia | 0/30 (0%) | 2/35 (5.7%) | 0/47 (0%) | 0/5 (0%) | 0/37 (0%) | |||||
| Oropharyngeal blistering | 0/30 (0%) | 1/35 (2.9%) | 0/47 (0%) | 1/5 (20%) | 1/37 (2.7%) | |||||
| Sinus congestion | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 1/5 (20%) | 0/37 (0%) | |||||
| Pulmonary congestion | 0/30 (0%) | 0/35 (0%) | 0/47 (0%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Ecchymosis | 2/30 (6.7%) | 5/35 (14.3%) | 9/47 (19.1%) | 0/5 (0%) | 6/37 (16.2%) | |||||
| Night sweats | 2/30 (6.7%) | 6/35 (17.1%) | 5/47 (10.6%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Rash | 2/30 (6.7%) | 2/35 (5.7%) | 6/47 (12.8%) | 0/5 (0%) | 3/37 (8.1%) | |||||
| Pruritus | 2/30 (6.7%) | 2/35 (5.7%) | 2/47 (4.3%) | 0/5 (0%) | 4/37 (10.8%) | |||||
| Petechiae | 2/30 (6.7%) | 0/35 (0%) | 4/47 (8.5%) | 0/5 (0%) | 2/37 (5.4%) | |||||
| Dry skin | 1/30 (3.3%) | 0/35 (0%) | 1/47 (2.1%) | 1/5 (20%) | 2/37 (5.4%) | |||||
| Erythema | 0/30 (0%) | 0/35 (0%) | 3/47 (6.4%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Photodermatosis | 1/30 (3.3%) | 2/35 (5.7%) | 0/47 (0%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Skin lesion | 0/30 (0%) | 2/35 (5.7%) | 1/47 (2.1%) | 0/5 (0%) | 1/37 (2.7%) | |||||
| Actinic keratosis | 0/30 (0%) | 0/35 (0%) | 1/47 (2.1%) | 1/5 (20%) | 0/37 (0%) | |||||
| Vascular disorders | ||||||||||
| Haematoma | 1/30 (3.3%) | 3/35 (8.6%) | 1/47 (2.1%) | 0/5 (0%) | 0/37 (0%) | |||||
| Hypertension | 0/30 (0%) | 2/35 (5.7%) | 1/47 (2.1%) | 1/5 (20%) | 1/37 (2.7%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 | 1-855-463-3463 |
Responsible Party:
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT00509899
Other Study ID Numbers:
- INCB 18424-251
First Posted:
Aug 1, 2007
Last Update Posted:
Mar 12, 2018
Last Verified:
Feb 1, 2018