Trial Outcomes & Findings for Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1) (NCT NCT02117479)
NCT ID: NCT02117479
Last Updated: 2019-03-26
Results Overview
Overall survival is reported here based on the number of deaths from randomization up to 6-months or to the data cutoff 11FEB2016.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
321 participants
Primary outcome timeframe
Randomization until death due to any cause; up to the data cutoff 11FEB2016.
Results posted on
2019-03-26
Participant Flow
Participants with advanced or metastatic adenocarcinoma of the pancreas who had failed or were intolerant to first-line chemotherapy were randomized in the study.
Treatment was started as soon as possible after randomization (within 3 days) and consisted of continuous 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered for the entire cycle.
Participant milestones
| Measure |
Ruxolitinib Plus Capecitabine
Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
Placebo Plus Capecitabine
Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
|---|---|---|
|
Overall Study
STARTED
|
161
|
160
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
156
|
156
|
Reasons for withdrawal
| Measure |
Ruxolitinib Plus Capecitabine
Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
Placebo Plus Capecitabine
Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
|---|---|---|
|
Overall Study
Death
|
13
|
8
|
|
Overall Study
Adverse Event
|
8
|
16
|
|
Overall Study
Subject decision
|
8
|
9
|
|
Overall Study
Disease progression
|
104
|
108
|
|
Overall Study
Noncompliance with study treatment
|
1
|
0
|
|
Overall Study
Study terminated by the sponsor
|
4
|
6
|
|
Overall Study
Physician Decision
|
7
|
2
|
|
Overall Study
Other unspecified
|
11
|
7
|
Baseline Characteristics
Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)
Baseline characteristics by cohort
| Measure |
Ruxolitinib Plus Capecitabine
n=161 Participants
Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
Placebo Plus Capecitabine
n=160 Participants
Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
Total
n=321 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 9.35 • n=5 Participants
|
65.6 years
STANDARD_DEVIATION 9.55 • n=7 Participants
|
66.4 years
STANDARD_DEVIATION 9.48 • n=5 Participants
|
|
Age, Customized
≤ 65 years
|
65 participants
n=5 Participants
|
68 participants
n=7 Participants
|
133 participants
n=5 Participants
|
|
Age, Customized
> 65 years
|
96 participants
n=5 Participants
|
92 participants
n=7 Participants
|
188 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization until death due to any cause; up to the data cutoff 11FEB2016.Population: The intent-to-treat (ITT) population consisted of all participants randomized to the study.
Overall survival is reported here based on the number of deaths from randomization up to 6-months or to the data cutoff 11FEB2016.
Outcome measures
| Measure |
Ruxolitinib Plus Capecitabine
n=161 Participants
Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
Placebo Plus Capecitabine
n=160 Participants
Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
|---|---|---|
|
Overall Survival (OS)
Observed
|
113 Participants
|
124 Participants
|
|
Overall Survival (OS)
Censored
|
48 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.Population: The intent-to-treat (ITT) population consisted of all participants randomized to the study.
Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.
Outcome measures
| Measure |
Ruxolitinib Plus Capecitabine
n=161 Participants
Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
Placebo Plus Capecitabine
n=160 Participants
Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
|---|---|---|
|
Progression-free Survival (PFS)
|
43.0 days
Interval 41.0 to 46.0
|
44.0 days
Interval 42.0 to 48.0
|
SECONDARY outcome
Timeframe: Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.Population: The intent-to-treat (ITT) population consisted of all participants randomized to the study.
PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.
Outcome measures
| Measure |
Ruxolitinib Plus Capecitabine
n=161 Participants
Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
Placebo Plus Capecitabine
n=160 Participants
Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
|---|---|---|
|
Percentage of Participants Achieving Progression Free Survival (PFS)
Survival rate at 3 months
|
18.9 percentage of participants
Interval 12.7 to 25.9
|
19.8 percentage of participants
Interval 13.6 to 26.8
|
|
Percentage of Participants Achieving Progression Free Survival (PFS)
Survival rate at 6 months
|
6.1 percentage of participants
Interval 2.5 to 12.2
|
5.7 percentage of participants
Interval 2.3 to 11.3
|
|
Percentage of Participants Achieving Progression Free Survival (PFS)
Survival rate at 9 months
|
2.5 percentage of participants
Interval 0.5 to 7.5
|
3.4 percentage of participants
Interval 1.0 to 8.5
|
|
Percentage of Participants Achieving Progression Free Survival (PFS)
Survival rate at 12 months
|
2.5 percentage of participants
Interval 0.5 to 7.5
|
NA percentage of participants
PFS was not evaluable in the placebo group due to the insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.Population: The intent-to-treat (ITT) population consisted of all participants randomized to the study.
Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Ruxolitinib Plus Capecitabine
n=161 Participants
Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
Placebo Plus Capecitabine
n=160 Participants
Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
|---|---|---|
|
Objective Response Rate (ORR)
Objective response
|
3.7 percentage of participants
|
1.9 percentage of participants
|
|
Objective Response Rate (ORR)
Complete response
|
0 percentage of participants
|
0 percentage of participants
|
|
Objective Response Rate (ORR)
Partial response
|
3.7 percentage of participants
|
1.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.Population: The intent-to-treat (ITT) population consisted of all participants randomized to the study.
Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) until the first date Progressive Disease (PD) was objectively documented or until the date of death.
Outcome measures
| Measure |
Ruxolitinib Plus Capecitabine
n=161 Participants
Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
Placebo Plus Capecitabine
n=160 Participants
Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
|---|---|---|
|
Duration of Response
|
NA days
The median duration of response was not evaluable in the treatment group due to the insufficient number of participants with events.
|
NA days
The median duration of response was not evaluable in the treatment group due to the insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.Population: The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug (ruxolitinib or placebo). A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).
Outcome measures
| Measure |
Ruxolitinib Plus Capecitabine
n=153 Participants
Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
Placebo Plus Capecitabine
n=154 Participants
Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
|---|---|---|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants who had any TEAEs
|
152 Participants
|
152 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants who had treatment-related TEAEs
|
73 Participants
|
59 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants who had SAEs
|
94 Participants
|
83 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants who had Grade 3 or higher TEAEs
|
112 Participants
|
113 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants hospitalized because of a TEAE
|
89 Participants
|
75 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants discontinued treatment due to TEAE
|
12 Participants
|
22 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with a dose modification due to TEAE
|
68 Participants
|
48 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants on concomitant medication due to TEAE
|
131 Participants
|
122 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with procedure performed due to TEAE
|
60 Participants
|
46 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants who had a fatal TEAE
|
20 Participants
|
15 Participants
|
Adverse Events
Ruxolitinib Plus Capecitabine
Serious events: 94 serious events
Other events: 147 other events
Deaths: 0 deaths
Placebo Plus Capecitabine
Serious events: 83 serious events
Other events: 145 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ruxolitinib Plus Capecitabine
n=153 participants at risk
Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
Placebo Plus Capecitabine
n=154 participants at risk
Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
4/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.9%
3/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.3%
2/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.3%
2/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Cardiac disorders
Cardiac arrest
|
1.3%
2/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Cardiac disorders
Cardiac failure
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Cardiac disorders
Coronary artery disease
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Cardiac disorders
Myocardial infarction
|
1.3%
2/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Eye disorders
Conjunctival haemorrhage
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Abdominal pain
|
3.9%
6/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
12.3%
19/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Ascites
|
3.3%
5/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Colitis
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Constipation
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.6%
4/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
5/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.6%
4/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Duodenal obstruction
|
1.3%
2/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.9%
3/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Dysphagia
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Enteritis
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Enterocolitis
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.3%
2/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Haematemesis
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Ileus
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.3%
2/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Melaena
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Nausea
|
2.6%
4/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
3.2%
5/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.3%
2/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Stomatitis
|
1.3%
2/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.9%
3/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Vomiting
|
4.6%
7/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.6%
4/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
General disorders
Asthenia
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.9%
3/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
General disorders
Device leakage
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
General disorders
Device malfunction
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
General disorders
Fatigue
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
General disorders
General physical health deterioration
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.9%
3/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
General disorders
Hypothermia
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
General disorders
Malaise
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
General disorders
Multi-organ failure
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
General disorders
Oedema
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
General disorders
Pain
|
2.0%
3/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.3%
2/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
General disorders
Pyrexia
|
5.2%
8/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.9%
3/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Hepatobiliary disorders
Biloma
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Hepatobiliary disorders
Cholangitis
|
2.0%
3/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.3%
2/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Hepatobiliary disorders
Hepatic failure
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.3%
2/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Hepatobiliary disorders
Jaundice
|
2.0%
3/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.9%
3/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.3%
2/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.3%
2/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Biliary tract infection
|
1.3%
2/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Bronchitis
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Candida infection
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Cholangitis suppurative
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Device related infection
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Escherichia infection
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Infection
|
1.3%
2/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Klebsiella infection
|
1.3%
2/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Klebsiella sepsis
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Liver abscess
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Peritonitis
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Peritonitis bacterial
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Pneumonia
|
2.6%
4/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
4.5%
7/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Sepsis
|
3.3%
5/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
3.2%
5/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Septic shock
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.3%
2/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Skin candida
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Urinary tract infection
|
1.3%
2/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Injury, poisoning and procedural complications
Fall
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Investigations
Blood bilirubin increased
|
2.6%
4/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Investigations
Liver function test abnormal
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Investigations
Platelet count decreased
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Investigations
Transaminases increased
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Investigations
White blood cell count decreased
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Metabolism and nutrition disorders
Dehydration
|
4.6%
7/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.6%
4/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.3%
2/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.0%
3/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.3%
2/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.3%
2/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.0%
3/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.3%
2/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.3%
2/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.3%
5/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.9%
3/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.3%
2/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.9%
3/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.3%
2/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma metastatic
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
1.3%
2/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Nervous system disorders
Headache
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Nervous system disorders
Ischaemic stroke
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Nervous system disorders
Parkinson's disease
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Nervous system disorders
Syncope
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Psychiatric disorders
Delirium
|
1.3%
2/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Psychiatric disorders
Mental status changes
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Renal and urinary disorders
Renal failure
|
2.0%
3/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Renal and urinary disorders
Renal failure acute
|
3.3%
5/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
5/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.6%
4/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
3.2%
5/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.3%
5/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.3%
2/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Vascular disorders
Embolism
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.3%
2/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Vascular disorders
Haematoma
|
0.65%
1/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.00%
0/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Vascular disorders
Hypertension
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Vascular disorders
Hypotension
|
2.0%
3/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.3%
2/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Vascular disorders
Phlebitis
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
0.65%
1/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
Other adverse events
| Measure |
Ruxolitinib Plus Capecitabine
n=153 participants at risk
Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
Placebo Plus Capecitabine
n=154 participants at risk
Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
29.4%
45/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
31.8%
49/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Blood and lymphatic system disorders
Anemia
|
29.4%
45/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
14.3%
22/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
General disorders
Fatigue
|
30.7%
47/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
32.5%
50/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Diarrhea
|
27.5%
42/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
23.4%
36/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Abdominal pain
|
23.5%
36/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
31.8%
49/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
24.2%
37/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
16.9%
26/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Vomiting
|
19.6%
30/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
29.9%
46/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Constipation
|
21.6%
33/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
17.5%
27/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Stomatitis
|
19.6%
30/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
11.7%
18/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.6%
30/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
30.5%
47/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
General disorders
Pyrexia
|
16.3%
25/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
8.4%
13/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Ascites
|
13.7%
21/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
13.0%
20/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.4%
19/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
10.4%
16/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Nervous system disorders
Dizziness
|
12.4%
19/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
7.8%
12/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
General disorders
Oedema peripheral
|
11.8%
18/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
22.7%
35/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
General disorders
Asthenia
|
11.1%
17/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
11.7%
18/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Abdominal distension
|
9.8%
15/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
7.1%
11/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Metabolism and nutrition disorders
Dehydration
|
6.5%
10/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
5.8%
9/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Vascular disorders
Hypotension
|
7.8%
12/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
5.2%
8/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.5%
13/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
9.1%
14/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.9%
9/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
3.2%
5/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Psychiatric disorders
Insomnia
|
8.5%
13/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
4.5%
7/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
9/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
12.3%
19/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
General disorders
Oedema
|
7.2%
11/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.9%
3/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Infections and infestations
Urinary tract infection
|
5.9%
9/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
3.9%
6/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Investigations
Aspartate aminotransferase increased
|
6.5%
10/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.9%
3/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
10/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
8.4%
13/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Injury, poisoning and procedural complications
Fall
|
6.5%
10/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.6%
4/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Investigations
Weight decreased
|
6.5%
10/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
3.9%
6/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
9/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.6%
4/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
9/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.9%
3/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.9%
9/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.3%
2/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.2%
8/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.3%
2/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.2%
8/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.6%
4/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
General disorders
Chills
|
5.2%
8/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.6%
4/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Vascular disorders
Hypertension
|
5.2%
8/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.9%
3/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.6%
7/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
3.2%
5/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.2%
8/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
1.3%
2/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.6%
4/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
5.8%
9/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Nervous system disorders
Dysgeusia
|
2.6%
4/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
5.2%
8/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Gastrointestinal disorders
Dry mouth
|
2.0%
3/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
5.2%
8/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
17/153 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
7.8%
12/154 • From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
Additional Information
Study Director
Incyte Corporation
Phone: 855 463-3463
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