Trial Outcomes & Findings for Study to Determine the Safety and Efficacy of INCB018424 in Patients With Polycythemia Vera or Essential Thrombocythemia (NCT NCT00726232)
NCT ID: NCT00726232
Last Updated: 2025-10-29
Results Overview
For a confirmed response all criteria must have been sustained for at least 2 months. CR: * Hematocrit \< 45% in men and \< 42% in women * No phlebotomy for 1 month * No palpable splenomegaly * White blood cells \< 10 x 10\^9/L with normal differential and platelets \< 400 x 10\^9/L * No sustained leucopenia or thrombocytopenia (\>2 weeks) * No systemic PV symptoms (pruritus, night sweats, bone pain, fever, weight loss) PR: * Hematocrit \< 45% in men and \< 42% in women * 50% reduction in phlebotomy requirements from 6 months before treatment started * 50% reduction in palpable splenomegaly
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
73 participants
Primary outcome timeframe
Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3
Results posted on
2025-10-29
Participant Flow
This was a multicenter study with 2 sites in the United States and 4 sites in Italy.
Participant milestones
| Measure |
Polycythemia Vera (PV): Ruxolitinib 10 mg BID
Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 25 mg BID
Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 50 mg QD
Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
Essential Thrombocythemia (ET): Ruxolitinib 10 mg BID
Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 25 mg BID
Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 50 mg QD
Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib All Doses Combined- Expansion Phase
After the completion of the dose-finding phase of the study, the starting dose of ruxolitinib for the expansion phase was determined to be 10 mg BID for subjects with PV. After subjects completed 8 weeks of ruxolitinib treatment at the starting dose, investigators were permitted to adjust the dose regimen to a maximum total daily dose of 75 mg on an individual basis, using their discretion, in order to achieve an optimal balance of efficacy and safety.
|
ET: Ruxolitinib All Doses Combined-expansion Phase
After the completion of the dose-finding phase of the study, the starting dose of ruxolitinib for the expansion phase was determined to be 25 mg BID for subjects with ET. After subjects completed 8 weeks of ruxolitinib treatment at the starting dose, investigators were permitted to adjust the dose regimen to a maximum total daily dose of 75 mg on an individual basis, using their discretion, in order to achieve an optimal balance of efficacy and safety.
|
|---|---|---|---|---|---|---|---|---|
|
Initial Phase (Dose-finding)
STARTED
|
19
|
8
|
7
|
8
|
22
|
9
|
0
|
0
|
|
Initial Phase (Dose-finding)
Safety Evaluable Participants
|
19
|
8
|
7
|
8
|
22
|
9
|
0
|
0
|
|
Initial Phase (Dose-finding)
ITT Participants
|
19
|
8
|
7
|
8
|
22
|
9
|
0
|
0
|
|
Initial Phase (Dose-finding)
COMPLETED
|
6
|
2
|
2
|
0
|
1
|
0
|
0
|
0
|
|
Initial Phase (Dose-finding)
NOT COMPLETED
|
13
|
6
|
5
|
8
|
21
|
9
|
0
|
0
|
|
Expansion Phase
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
34
|
39
|
|
Expansion Phase
Safety Evaluable Participants
|
0
|
0
|
0
|
0
|
0
|
0
|
34
|
39
|
|
Expansion Phase
ITT Participants
|
0
|
0
|
0
|
0
|
0
|
0
|
34
|
39
|
|
Expansion Phase
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
1
|
|
Expansion Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
24
|
38
|
Reasons for withdrawal
| Measure |
Polycythemia Vera (PV): Ruxolitinib 10 mg BID
Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 25 mg BID
Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 50 mg QD
Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
Essential Thrombocythemia (ET): Ruxolitinib 10 mg BID
Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 25 mg BID
Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 50 mg QD
Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib All Doses Combined- Expansion Phase
After the completion of the dose-finding phase of the study, the starting dose of ruxolitinib for the expansion phase was determined to be 10 mg BID for subjects with PV. After subjects completed 8 weeks of ruxolitinib treatment at the starting dose, investigators were permitted to adjust the dose regimen to a maximum total daily dose of 75 mg on an individual basis, using their discretion, in order to achieve an optimal balance of efficacy and safety.
|
ET: Ruxolitinib All Doses Combined-expansion Phase
After the completion of the dose-finding phase of the study, the starting dose of ruxolitinib for the expansion phase was determined to be 25 mg BID for subjects with ET. After subjects completed 8 weeks of ruxolitinib treatment at the starting dose, investigators were permitted to adjust the dose regimen to a maximum total daily dose of 75 mg on an individual basis, using their discretion, in order to achieve an optimal balance of efficacy and safety.
|
|---|---|---|---|---|---|---|---|---|
|
Initial Phase (Dose-finding)
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Initial Phase (Dose-finding)
Adverse Event
|
2
|
2
|
2
|
1
|
7
|
3
|
0
|
0
|
|
Initial Phase (Dose-finding)
Withdrawal by Subject
|
2
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
|
Initial Phase (Dose-finding)
Disease progression
|
3
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initial Phase (Dose-finding)
Termination of the trial by sponsor
|
4
|
3
|
3
|
4
|
9
|
3
|
0
|
0
|
|
Initial Phase (Dose-finding)
Per Investigator: lack of response
|
1
|
0
|
0
|
2
|
4
|
1
|
0
|
0
|
|
Initial Phase (Dose-finding)
Unspecified reason
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Expansion Phase
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Expansion Phase
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
11
|
|
Expansion Phase
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
3
|
|
Expansion Phase
Disease progression
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
|
Expansion Phase
Termination of the trial by sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
16
|
|
Expansion Phase
Per Investigator: lack of response
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
7
|
|
Expansion Phase
Unspecified reason
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study to Determine the Safety and Efficacy of INCB018424 in Patients With Polycythemia Vera or Essential Thrombocythemia
Baseline characteristics by cohort
| Measure |
PV: Ruxolitinib 10 mg BID
n=19 Participants
Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 25 mg BID
n=8 Participants
Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 50 mg QD
n=7 Participants
Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 10 mg BID
n=8 Participants
Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 25 mg BID
n=22 Participants
Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 50 mg QD
n=9 Participants
Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
Polycythemia vera group
|
56.3 years
STANDARD_DEVIATION 10.98 • n=5 Participants
|
57.0 years
STANDARD_DEVIATION 11.26 • n=7 Participants
|
51.0 years
STANDARD_DEVIATION 20.49 • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=4 Participants
|
NA years
STANDARD_DEVIATION NA • n=21 Participants
|
NA years
STANDARD_DEVIATION NA • n=8 Participants
|
55.4 years
STANDARD_DEVIATION 13.20 • n=8 Participants
|
|
Age, Continuous
Essential thrombocythemia group
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
49.6 years
STANDARD_DEVIATION 17.89 • n=4 Participants
|
54.1 years
STANDARD_DEVIATION 11.55 • n=21 Participants
|
52.8 years
STANDARD_DEVIATION 13.48 • n=8 Participants
|
52.9 years
STANDARD_DEVIATION 13.19 • n=8 Participants
|
|
Age, Customized
>= 65
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=8 Participants
|
17 participants
n=8 Participants
|
|
Age, Customized
< 65
|
14 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
7 participants
n=4 Participants
|
19 participants
n=21 Participants
|
6 participants
n=8 Participants
|
56 participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
42 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
|
Hematocrit
Hematocrit ≥ 45%
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
0 participants
n=8 Participants
|
28 participants
n=8 Participants
|
|
Hematocrit
Hematocrit < 45%
|
9 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
7 participants
n=4 Participants
|
18 participants
n=21 Participants
|
9 participants
n=8 Participants
|
45 participants
n=8 Participants
|
|
Platelet count
≥400 x 10^9 per liter
|
13 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
7 participants
n=4 Participants
|
22 participants
n=21 Participants
|
9 participants
n=8 Participants
|
61 participants
n=8 Participants
|
|
Platelet count
< 400 x 10^9 per liter
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
12 participants
n=8 Participants
|
|
White blood cell count
≥ 10 x 10^9 per liter
|
12 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
2 participants
n=4 Participants
|
7 participants
n=21 Participants
|
2 participants
n=8 Participants
|
36 participants
n=8 Participants
|
|
White blood cell count
< 10 x 10^9 per liter
|
7 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
6 participants
n=4 Participants
|
15 participants
n=21 Participants
|
7 participants
n=8 Participants
|
37 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3Population: Polycythemia Vera intent to treat population, including all patients who took at least 1 dose of study drug.
For a confirmed response all criteria must have been sustained for at least 2 months. CR: * Hematocrit \< 45% in men and \< 42% in women * No phlebotomy for 1 month * No palpable splenomegaly * White blood cells \< 10 x 10\^9/L with normal differential and platelets \< 400 x 10\^9/L * No sustained leucopenia or thrombocytopenia (\>2 weeks) * No systemic PV symptoms (pruritus, night sweats, bone pain, fever, weight loss) PR: * Hematocrit \< 45% in men and \< 42% in women * 50% reduction in phlebotomy requirements from 6 months before treatment started * 50% reduction in palpable splenomegaly
Outcome measures
| Measure |
PV: Ruxolitinib 10 mg BID
n=19 Participants
Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 25 mg BID
n=8 Participants
Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 50 mg QD
n=7 Participants
Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 10 mg BID
Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 25 mg BID
Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 50 mg QD
Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
|---|---|---|---|---|---|---|
|
Percentage of Polycythemia Vera Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR)
|
58 percentage of participants
|
50 percentage of participants
|
57 percentage of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3.Population: Essential thrombocythemia intent to treat population, including all patients who took at least 1 dose of study drug. One patient in the 50 mg QD group did not have a response assessment at Cycle 3, Day 1.
For a confirmed response all criteria must have been sustained for at least 2 months. Complete Clinical Response: * Platelet count \< 400 x 10\^9/L * White blood cell count \< 10 x 10\^9/L with normal differential and Hematocrit ≤ upper limit of normal * Absence of sustained (\> 2 weeks) anemia or leucopenia based on institutional normal ranges * Absence of systemic ET symptoms (pruritus, bone pain, weakness, night sweats, paresthesias) * Absence of palpable splenomegaly Partial Clinical Response: * Platelet count \< 400 x 10\^9/L * 50% reduction in palpable splenomegaly
Outcome measures
| Measure |
PV: Ruxolitinib 10 mg BID
n=8 Participants
Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 25 mg BID
n=22 Participants
Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 50 mg QD
n=8 Participants
Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 10 mg BID
Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 25 mg BID
Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 50 mg QD
Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
|---|---|---|---|---|---|---|
|
Percentage of Essential Thrombocythemia (ET) Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR)
|
13 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12 (Cycle 4, Day 1)Population: Polycythemia Vera intent to treat population for whom data was available.
The individual components of clinical response included: * Hematocrit (Hct) \< 45% without phlebotomy * Absence of palpable splenomegaly * 50% reduction in spleen size * Platelet count ≤ 400 x 10\^9/L * White blood cell (WBC) count ≤ 10 x 10\^9/L
Outcome measures
| Measure |
PV: Ruxolitinib 10 mg BID
n=19 Participants
Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 25 mg BID
n=8 Participants
Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 50 mg QD
n=7 Participants
Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 10 mg BID
Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 25 mg BID
Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 50 mg QD
Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
|---|---|---|---|---|---|---|
|
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks
50% reduction in spleen size
|
74 percentage of participants
|
63 percentage of participants
|
86 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks
Platelet count ≤ 400 x 10^9/L
|
58 percentage of participants
|
50 percentage of participants
|
57 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks
WBC count ≤ 10 x 10^9/L
|
68 percentage of participants
|
63 percentage of participants
|
43 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks
Hematocrit <45% Without Phlebotomy
|
95 percentage of participants
|
88 percentage of participants
|
86 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks
Absence of palpable splenomegaly
|
68 percentage of participants
|
50 percentage of participants
|
57 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24 (Cycle 7, Day 1)Population: Polycythemia Vera intent to treat population for whom data was available. 'N' indicates the number of patients for whom data was available for each component.
The individual components of clinical response included: * Hematocrit (Hct) \< 45% without phlebotomy * Absence of palpable splenomegaly * 50% reduction in spleen size * Platelet count ≤ 400 x 10\^9/L * White blood cell (WBC) count ≤ 10 x 10\^9/L
Outcome measures
| Measure |
PV: Ruxolitinib 10 mg BID
n=19 Participants
Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 25 mg BID
n=8 Participants
Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 50 mg QD
n=7 Participants
Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 10 mg BID
Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 25 mg BID
Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 50 mg QD
Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
|---|---|---|---|---|---|---|
|
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 24 Weeks
Hematocrit <45% Without Phlebotomy
|
100 percentage of participants
|
88 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 24 Weeks
Absence of palpable splenomegaly
|
61 percentage of participants
|
43 percentage of participants
|
71 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 24 Weeks
50% reduction in spleen size
|
78 percentage of participants
|
71 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 24 Weeks
Platelet count ≤ 400 x 10^9/L
|
58 percentage of participants
|
88 percentage of participants
|
86 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 24 Weeks
WBC count ≤ 10 x 10^9/L
|
74 percentage of participants
|
25 percentage of participants
|
86 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 36 (Cycle 10, Day 1)Population: Polycythemia Vera intent to treat population for whom data was available. 'N' indicates the number of patients for whom data was available for each component.
The individual components of clinical response included: * Hematocrit (Hct) \< 45% without phlebotomy * Absence of palpable splenomegaly * 50% reduction in spleen size * Platelet count ≤ 400 x 10\^9/L * White blood cell (WBC) count ≤ 10 x 10\^9/L
Outcome measures
| Measure |
PV: Ruxolitinib 10 mg BID
n=18 Participants
Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 25 mg BID
n=8 Participants
Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 50 mg QD
n=7 Participants
Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 10 mg BID
Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 25 mg BID
Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 50 mg QD
Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
|---|---|---|---|---|---|---|
|
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 36 Weeks
Absence of palpable splenomegaly
|
71 percentage of participants
|
57 percentage of participants
|
86 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 36 Weeks
50% reduction in spleen size
|
76 percentage of participants
|
71 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 36 Weeks
Hematocrit <45% Without Phlebotomy
|
100 percentage of participants
|
88 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 36 Weeks
Platelet count ≤ 400 x 10^9/L
|
67 percentage of participants
|
75 percentage of participants
|
86 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 36 Weeks
WBC count ≤ 10 x 10^9/L
|
67 percentage of participants
|
25 percentage of participants
|
71 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks (Cycle 2, Day 1)Population: Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component.
The individual components of clinical response included: * Platelet count ≤ 400 x 10\^9/L * White blood cell (WBC) count ≤ 10 x 10\^9/L * 50% reduction in spleen size * Absence of palpable splenomegaly
Outcome measures
| Measure |
PV: Ruxolitinib 10 mg BID
n=8 Participants
Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 25 mg BID
n=22 Participants
Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 50 mg QD
n=9 Participants
Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 10 mg BID
Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 25 mg BID
Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 50 mg QD
Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
|---|---|---|---|---|---|---|
|
Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 4 Weeks
Platelet count ≤ 400 x 10^9/L
|
25 percentage of participants
|
41 percentage of participants
|
33 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 4 Weeks
WBC count ≤ 10 x 10^9/L
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 4 Weeks
50% reduction in spleen size
|
83 percentage of participants
|
95 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 4 Weeks
Absence of palpable splenomegaly
|
67 percentage of participants
|
89 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 24 weeks (Cycle 7, Day 1)Population: Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component.
The individual components of clinical response included: * Platelet count ≤ 400 x 10\^9/L * White blood cell (WBC) count ≤ 10 x 10\^9/L * 50% reduction in spleen size * Absence of palpable splenomegaly
Outcome measures
| Measure |
PV: Ruxolitinib 10 mg BID
n=8 Participants
Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 25 mg BID
n=22 Participants
Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 50 mg QD
n=9 Participants
Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 10 mg BID
Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 25 mg BID
Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 50 mg QD
Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
|---|---|---|---|---|---|---|
|
Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 24 Weeks
Platelet count ≤ 400 x 10^9/L
|
14 percentage of participants
|
5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 24 Weeks
WBC count ≤ 10 x 10^9/L
|
100 percentage of participants
|
86 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 24 Weeks
50% reduction in spleen size
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 24 Weeks
Absence of palpable splenomegaly
|
100 percentage of participants
|
95 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 36 weeks (Cycle 10, Day 1)Population: Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component.
The individual components of clinical response included: * Platelet count ≤ 400 x 10\^9/L * White blood cell (WBC) count ≤ 10 x 10\^9/L * 50% reduction in spleen size * Absence of palpable splenomegaly
Outcome measures
| Measure |
PV: Ruxolitinib 10 mg BID
n=8 Participants
Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 25 mg BID
n=22 Participants
Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 50 mg QD
n=9 Participants
Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 10 mg BID
Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 25 mg BID
Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 50 mg QD
Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
|---|---|---|---|---|---|---|
|
Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 36 Weeks
Platelet count ≤ 400 x 10^9/L
|
14 percentage of participants
|
11 percentage of participants
|
14 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 36 Weeks
WBC count ≤ 10 x 10^9/L
|
100 percentage of participants
|
79 percentage of participants
|
86 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 36 Weeks
50% reduction in spleen size
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 36 Weeks
Absence of palpable splenomegaly
|
100 percentage of participants
|
94 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4 (Cycle 2, Day 1)Population: Polycythemia Vera intent to treat population who had symptom scores \> 0 at baseline for whom data was available.
Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms. For patients with Polycythemia Vera, queried symptoms included fever, itching/pruritus, bone pain and night sweats.
Outcome measures
| Measure |
PV: Ruxolitinib 10 mg BID
n=19 Participants
Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 25 mg BID
n=8 Participants
Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 50 mg QD
n=7 Participants
Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 10 mg BID
Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 25 mg BID
Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 50 mg QD
Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
|---|---|---|---|---|---|---|
|
Change From Baseline to Week 4 in Polycythemia Vera Symptoms
Itching (pruritus)
|
-4.2 scores on a scale
Standard Deviation 3.63
|
-4.6 scores on a scale
Standard Deviation 1.85
|
-2.8 scores on a scale
Standard Deviation 4.09
|
—
|
—
|
—
|
|
Change From Baseline to Week 4 in Polycythemia Vera Symptoms
Bone pain
|
-2.0 scores on a scale
Standard Deviation 1.95
|
-2.5 scores on a scale
Standard Deviation 0.71
|
-4.3 scores on a scale
Standard Deviation 2.08
|
—
|
—
|
—
|
|
Change From Baseline to Week 4 in Polycythemia Vera Symptoms
Fever
|
-2.0 scores on a scale
Standard Deviation 1.41
|
—
|
-2.0 scores on a scale
Standard Deviation 1.41
|
—
|
—
|
—
|
|
Change From Baseline to Week 4 in Polycythemia Vera Symptoms
Night sweats
|
-1.9 scores on a scale
Standard Deviation 2.52
|
-2.8 scores on a scale
Standard Deviation 3.19
|
-3.3 scores on a scale
Standard Deviation 1.15
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4 (Cycle 2, Day 1)Population: Essential Thrombocythemia intent to treat population who had symptom scores \> 0 at baseline and for whom data was available.
Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms. For patients with essential thrombocythemia, queried symptoms included itching/pruritus, bone pain, night sweats, paresthesias (tingling or numbness), and weakness.
Outcome measures
| Measure |
PV: Ruxolitinib 10 mg BID
n=8 Participants
Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 25 mg BID
n=22 Participants
Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 50 mg QD
n=8 Participants
Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 10 mg BID
Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 25 mg BID
Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 50 mg QD
Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
|---|---|---|---|---|---|---|
|
Change From Baseline to Week 4 in Essential Thrombocythemia Symptoms
Itching (pruritus)
|
-2.7 score on a scale
Standard Deviation 2.89
|
-1.2 score on a scale
Standard Deviation 2.74
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Week 4 in Essential Thrombocythemia Symptoms
Night Sweats
|
-5.0 score on a scale
Standard Deviation NA
Only one patient available for this analysis
|
-1.3 score on a scale
Standard Deviation 2.49
|
-4.0 score on a scale
Standard Deviation 4.36
|
—
|
—
|
—
|
|
Change From Baseline to Week 4 in Essential Thrombocythemia Symptoms
Weakness
|
-1.0 score on a scale
Standard Deviation 1.00
|
-0.2 score on a scale
Standard Deviation 2.46
|
-1.7 score on a scale
Standard Deviation 2.52
|
—
|
—
|
—
|
|
Change From Baseline to Week 4 in Essential Thrombocythemia Symptoms
Bone pain
|
-3.5 score on a scale
Standard Deviation 2.12
|
-0.4 score on a scale
Standard Deviation 2.26
|
-2.3 score on a scale
Standard Deviation 4.93
|
—
|
—
|
—
|
|
Change From Baseline to Week 4 in Essential Thrombocythemia Symptoms
Paresthesia
|
-1.7 score on a scale
Standard Deviation 2.08
|
-1.6 score on a scale
Standard Deviation 1.50
|
-2.8 score on a scale
Standard Deviation 2.93
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4 (Cycle 2, Day 1)Population: Intent to treat population. The intent-to-treat (ITT) population included all subjects who took at least 1 dose of study drug.
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.
Outcome measures
| Measure |
PV: Ruxolitinib 10 mg BID
n=19 Participants
Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 25 mg BID
n=8 Participants
Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 50 mg QD
n=7 Participants
Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 10 mg BID
n=8 Participants
Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 25 mg BID
n=22 Participants
Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 50 mg QD
n=9 Participants
Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
|---|---|---|---|---|---|---|
|
Change From Baseline to Week 4 in Health-related Quality of Life
|
10.9 units on a scale
Standard Deviation 10.80
|
6.3 units on a scale
Standard Deviation 14.0
|
14.6 units on a scale
Standard Deviation 17.78
|
-2.1 units on a scale
Standard Deviation 10.5
|
3.0 units on a scale
Standard Deviation 27.6
|
11.2 units on a scale
Standard Deviation 23.4
|
Adverse Events
PV: Ruxolitinib 10 mg BID
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
PV: Ruxolitinib 25 mg BID
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
PV: Ruxolitinib 50 mg QD
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
ET: Ruxolitinib 10 mg BID
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
ET: Ruxolitinib 25 mg BID
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
ET: Ruxolitinib 50 mg QD
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
PV: Ruxolitinib All Doses Combined- Expansion Phase
Serious events: 17 serious events
Other events: 34 other events
Deaths: 0 deaths
ET: Ruxolitinib All Doses Combined-expansion Phase
Serious events: 17 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PV: Ruxolitinib 10 mg BID
n=19 participants at risk
Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 25 mg BID
n=8 participants at risk
Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 50 mg QD
n=7 participants at risk
Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 10 mg BID
n=8 participants at risk
Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 25 mg BID
n=22 participants at risk
Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 50 mg QD
n=9 participants at risk
Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib All Doses Combined- Expansion Phase
n=34 participants at risk
After the completion of the dose-finding phase of the study, the starting dose of ruxolitinib for the expansion phase was determined to be 10 mg BID for subjects with PV. After subjects completed 8 weeks of ruxolitinib treatment at the starting dose, investigators were permitted to adjust the dose regimen to a maximum total daily dose of 75 mg on an individual basis, using their discretion, in order to achieve an optimal balance of efficacy and safety.
|
ET: Ruxolitinib All Doses Combined-expansion Phase
n=39 participants at risk
After the completion of the dose-finding phase of the study, the starting dose of ruxolitinib for the expansion phase was determined to be 25 mg BID for subjects with ET. After subjects completed 8 weeks of ruxolitinib treatment at the starting dose, investigators were permitted to adjust the dose regimen to a maximum total daily dose of 75 mg on an individual basis, using their discretion, in order to achieve an optimal balance of efficacy and safety.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
4.5%
1/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
8.8%
3/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Progressive multifocal leukoencephalopathy
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue cancer recurrent
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.9%
1/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestine ulcer
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Lung infection
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Pneumococcal bacteraemia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteitis deformans
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paget's disease of the vulva
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
2.6%
1/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
Other adverse events
| Measure |
PV: Ruxolitinib 10 mg BID
n=19 participants at risk
Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 25 mg BID
n=8 participants at risk
Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib 50 mg QD
n=7 participants at risk
Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 10 mg BID
n=8 participants at risk
Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 25 mg BID
n=22 participants at risk
Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
ET: Ruxolitinib 50 mg QD
n=9 participants at risk
Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
|
PV: Ruxolitinib All Doses Combined- Expansion Phase
n=34 participants at risk
After the completion of the dose-finding phase of the study, the starting dose of ruxolitinib for the expansion phase was determined to be 10 mg BID for subjects with PV. After subjects completed 8 weeks of ruxolitinib treatment at the starting dose, investigators were permitted to adjust the dose regimen to a maximum total daily dose of 75 mg on an individual basis, using their discretion, in order to achieve an optimal balance of efficacy and safety.
|
ET: Ruxolitinib All Doses Combined-expansion Phase
n=39 participants at risk
After the completion of the dose-finding phase of the study, the starting dose of ruxolitinib for the expansion phase was determined to be 25 mg BID for subjects with ET. After subjects completed 8 weeks of ruxolitinib treatment at the starting dose, investigators were permitted to adjust the dose regimen to a maximum total daily dose of 75 mg on an individual basis, using their discretion, in order to achieve an optimal balance of efficacy and safety.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
17.6%
6/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
25.6%
10/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.8%
4/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
8.8%
3/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.8%
4/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.7%
5/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Endocrine disorders
Goitre
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Endocrine disorders
thyroid mass
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Eye disorders
Photopsia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.1%
4/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
25.0%
2/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
18.2%
4/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
33.3%
3/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
35.3%
12/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
30.8%
12/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
3/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
4.5%
1/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
33.3%
3/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
26.5%
9/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
17.9%
7/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Investigations
Cardiac murmur
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.5%
2/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
9.1%
2/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
17.6%
6/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Investigations
Platelet count increased
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
18.2%
4/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.8%
4/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
15.4%
6/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
10.3%
4/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
9.1%
2/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
17.6%
6/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.8%
5/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
10.3%
4/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Dental discomfort
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
84.2%
16/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
75.0%
6/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
42.9%
3/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
62.5%
5/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
86.4%
19/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
66.7%
6/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
79.4%
27/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
82.1%
32/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
31.6%
6/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
50.0%
4/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
50.0%
17/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
21.1%
4/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
9.1%
2/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
23.5%
8/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
10.5%
2/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
18.2%
4/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.8%
4/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
15.4%
6/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
8.8%
3/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
4.5%
1/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Eye disorders
Conjunctivitis
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
8.8%
3/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Eye disorders
Conjunctival haemorrhage
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Eye disorders
Eye pain
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Eye disorders
Myodesopsia
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Eye disorders
Photophobia
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
8.8%
3/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Eye disorders
Visual impairment
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
9.1%
2/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
9.1%
2/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
22.2%
2/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.8%
4/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
23.1%
9/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.8%
4/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
10.3%
4/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
9.1%
2/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
8.8%
3/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.8%
5/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
General disorders
Pyrexia
|
21.1%
4/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
25.0%
2/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
18.2%
4/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
38.2%
13/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
41.0%
16/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
General disorders
Asthenia
|
10.5%
2/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
25.0%
2/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
4.5%
1/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
26.5%
9/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
17.9%
7/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
General disorders
Fatigue
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
9.1%
2/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
22.2%
2/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.7%
5/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.8%
5/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.8%
4/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.8%
5/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
General disorders
Chest pain
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
28.6%
2/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
10.5%
2/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
4.5%
1/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
23.5%
8/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
20.5%
8/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
28.6%
2/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
9.1%
2/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
26.5%
9/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
10.3%
4/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
25.0%
2/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
23.5%
8/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
10.3%
4/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Cystitis
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
4.5%
1/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
20.6%
7/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
15.4%
6/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
4.5%
1/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.8%
4/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
10.3%
4/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Oral herpes
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.7%
5/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
10.5%
2/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
8.8%
3/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.8%
5/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
25.0%
2/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
4.5%
1/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
26.5%
9/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
28.2%
11/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Ear infection
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
8.8%
3/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Epstein-Barr virus infection
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Tooth infection
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
8.8%
3/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Investigations
Weight increased
|
10.5%
2/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
28.6%
2/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
25.0%
2/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
22.7%
5/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
33.3%
3/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
20.6%
7/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
35.9%
14/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
22.2%
2/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
8.8%
3/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.8%
4/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.8%
4/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
10.3%
4/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
17.6%
6/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Investigations
Transaminases increased
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
4.5%
1/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.8%
4/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
28.2%
11/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
10.5%
2/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
13.6%
3/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
17.6%
6/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
15.4%
6/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
23.5%
8/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
15.4%
6/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
8.8%
3/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
4.5%
1/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.8%
3/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
4.5%
1/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
32.4%
11/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
20.5%
8/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
2/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
4.5%
1/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
23.5%
8/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
28.2%
11/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
4.5%
1/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.7%
5/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
10.3%
4/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
4.5%
1/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.8%
4/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
10.3%
4/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
17.9%
7/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
18.2%
4/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
17.6%
6/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
28.2%
11/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
4.5%
1/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
8.8%
3/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
10.5%
2/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
13.6%
3/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
17.6%
6/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.8%
5/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
10.5%
2/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
27.3%
6/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
22.2%
2/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.8%
4/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
25.6%
10/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Nervous system disorders
Perineurial cyst
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Nervous system disorders
Restless legs syndrome
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
28.6%
2/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
4.5%
1/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.7%
5/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
10.3%
4/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
2/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
18.2%
4/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
35.3%
12/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
30.8%
12/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.5%
2/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
4.5%
1/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.8%
4/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
10.3%
4/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
28.6%
2/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
4.5%
1/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
8.8%
3/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.5%
2/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
9.1%
2/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.7%
5/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
10.3%
4/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Mucocutaneous rash
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
4.5%
1/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
17.6%
6/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
15.4%
6/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.3%
1/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
5.3%
1/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
25.0%
2/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
14.7%
5/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
20.5%
8/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
12.5%
1/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.1%
1/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Eye disorders
Cataract
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
8.8%
3/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
11.8%
4/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
7.7%
3/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
8.8%
3/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
8.8%
3/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
10.3%
4/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
15.4%
6/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/19 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/7 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/8 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/22 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
0.00%
0/9 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.9%
2/34 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
5.1%
2/39 • From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study; provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER