Trial Outcomes & Findings for A Study of Ruxolitinib in Pancreatic Cancer Patients (NCT NCT02119663)
NCT ID: NCT02119663
Last Updated: 2018-02-13
Results Overview
Overall survival is reported here based on the number of deaths from randomization until the data cut-off.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
86 participants
Primary outcome timeframe
Randomization until death due to any cause up to 6-months or to the data cutoff 11FEB2016.
Results posted on
2018-02-13
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
|
43
|
43
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
40
|
41
|
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
Disease progression
|
26
|
27
|
|
Overall Study
Adverse Event
|
5
|
5
|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Other unspecified
|
2
|
0
|
|
Overall Study
Subject decision
|
0
|
1
|
|
Overall Study
Study Terminated by the Sponsor
|
3
|
4
|
Baseline Characteristics
A Study of Ruxolitinib in Pancreatic Cancer Patients
Baseline characteristics by cohort
| Measure |
Ruxolitinib Plus Capecitabine
n=43 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=43 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=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 10.63 • n=5 Participants
|
68.8 years
STANDARD_DEVIATION 8.43 • n=7 Participants
|
67.1 years
STANDARD_DEVIATION 9.68 • n=5 Participants
|
|
Age, Customized
≤ 65 years
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Customized
> 65 years
|
23 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization until death due to any cause 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.
Overall survival is reported here based on the number of deaths from randomization until the data cut-off.
Outcome measures
| Measure |
Ruxolitinib Plus Capecitabine
n=43 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=43 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 deaths
|
29 Participants
|
23 Participants
|
|
Overall Survival (OS)
Censored deaths
|
14 Participants
|
20 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.
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 as 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=43 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=43 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)
|
48.0 days
Interval 37.0 to 83.0
|
61.0 days
Interval 41.0 to 86.0
|
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=43 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=43 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
|
0.337 percentage of participants
Interval 0.187 to 0.494
|
0.297 percentage of participants
Interval 0.157 to 0.451
|
|
Percentage of Participants Achieving Progression Free Survival (PFS)
Survival rate at 6 months
|
0.131 percentage of participants
Interval 0.037 to 0.287
|
0.204 percentage of participants
Interval 0.088 to 0.352
|
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 Response Evaluation Criteria in Solid Tumours RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by RECIST at any post baseline visit. Per 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=43 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=43 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
|
4.7 percentage of participants
|
2.3 percentage of participants
|
|
Objective Response Rate (ORR)
Complete response
|
2.3 percentage of participants
|
0.0 percentage of participants
|
|
Objective Response Rate (ORR)
Partial response
|
2.3 percentage of participants
|
2.3 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. Per 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=43 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=43 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=42 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=43 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 SAEs
|
28 Participants
|
20 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants who had Grade 3 or higher TEAEs
|
31 Participants
|
31 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with procedure performed due to TEAE
|
22 Participants
|
14 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants hospitalized because of a TEAE
|
26 Participants
|
18 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants discontinued treatment due to TEAE
|
7 Participants
|
5 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with a dose modification due to TEAE
|
17 Participants
|
14 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants on concomitant medication due to TEAE
|
36 Participants
|
35 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants who had any TEAEs
|
41 Participants
|
40 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants who had treatment-related TEAEs
|
21 Participants
|
25 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants who had a fatal TEAE
|
8 Participants
|
2 Participants
|
Adverse Events
Ruxolitinib Plus Capecitabine
Serious events: 28 serious events
Other events: 38 other events
Deaths: 0 deaths
Placebo Plus Capecitabine
Serious events: 20 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ruxolitinib Plus Capecitabine
n=42 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=43 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
Abdominal pain
|
9.5%
4/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
4.7%
2/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
4.8%
2/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
7.1%
3/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
9.3%
4/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
7.1%
3/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
11.6%
5/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
7.1%
3/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
4.8%
2/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Transient ischaemic attack
|
4.8%
2/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Dyspnea
|
9.5%
4/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
4.8%
2/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
4.7%
2/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
4.7%
2/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
4.8%
2/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
7.0%
3/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
4.8%
2/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
4.7%
2/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Atrial fibrillation
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
4.7%
2/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Gastric stenosis
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Gait disturbance
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Sudden cardiac death
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Sudden death
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Cellulitis
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Humerus fracture
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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 chest pain
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Spinal pain
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Cerebral ischaemia
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Cognitive disorder
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Hepatic encephalopathy
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Rash
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Deep vein thrombosis
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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=42 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=43 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).
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
7/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
23.3%
10/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
16.7%
7/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
18.6%
8/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
11.9%
5/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
11.6%
5/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Anaemia
|
38.1%
16/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
23.3%
10/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
33.3%
14/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
9.3%
4/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
26.2%
11/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
23.3%
10/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
23.8%
10/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
27.9%
12/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
23.8%
10/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
23.3%
10/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
23.8%
10/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
25.6%
11/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
23.8%
10/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
23.3%
10/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
23.8%
10/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
9.3%
4/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
21.4%
9/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
34.9%
15/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
19.0%
8/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
25.6%
11/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
14.3%
6/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
11.6%
5/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
16.7%
7/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
9.3%
4/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
11.9%
5/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
7.0%
3/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
14.3%
6/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
7.0%
3/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
11.9%
5/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
7.0%
3/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
9.5%
4/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
4.7%
2/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
11.9%
5/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
4.7%
2/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
9.5%
4/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
16.3%
7/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
9.5%
4/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
9.3%
4/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
7.1%
3/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
7.0%
3/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
9.5%
4/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
9.5%
4/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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 hyperpigmentation
|
9.5%
4/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
7.1%
3/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
14.0%
6/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
7.1%
3/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
9.3%
4/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
7.1%
3/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
4.7%
2/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
7.1%
3/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
4.7%
2/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Depression
|
7.1%
3/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Dry skin
|
7.1%
3/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
2.3%
1/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
7.1%
3/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Chest pain
|
7.1%
3/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Hematuria
|
7.1%
3/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Hypoalbuminaemia
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
11.6%
5/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
9.3%
4/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
7.0%
3/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
7.0%
3/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
7.0%
3/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
9.3%
4/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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 creatinine increased
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
7.0%
3/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
7.0%
3/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
7.0%
3/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
7.0%
3/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
7.0%
3/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Rash
|
0.00%
0/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
7.0%
3/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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
Hypophosphataemia
|
2.4%
1/42 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
|
7.0%
3/43 • From the first dose of study medication through the double-blind period through study termination up to 6-months or to 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