Trial Outcomes & Findings for A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer (NCT NCT02120417)
NCT ID: NCT02120417
Last Updated: 2018-02-13
Results Overview
Overall survival is reported here by the number of days from randomization to death until the data cutoff for the final analysis. The hazard ratio (80% CI) for ruxolitinib versus placebo was estimated using a Cox regression model stratified by hormone-receptor status.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
149 participants
Primary outcome timeframe
Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
Results posted on
2018-02-13
Participant Flow
This study was conducted at 72 study centers (65 in the United States and 7 in the European Union \[3 in the United Kingdom, 3 in Spain, and 1 in Portugal\]).
Participant milestones
| Measure |
Treatment A - Capecitabine and Ruxolitinib
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
Treatment B - Capecitabine and Placebo
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
73
|
|
Overall Study
COMPLETED
|
16
|
5
|
|
Overall Study
NOT COMPLETED
|
60
|
68
|
Reasons for withdrawal
| Measure |
Treatment A - Capecitabine and Ruxolitinib
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
Treatment B - Capecitabine and Placebo
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
|---|---|---|
|
Overall Study
Death
|
5
|
1
|
|
Overall Study
Adverse Event
|
3
|
9
|
|
Overall Study
Participant decision
|
4
|
4
|
|
Overall Study
Disease progression
|
41
|
45
|
|
Overall Study
Noncompliance with study treatment
|
0
|
2
|
|
Overall Study
Physician Decision
|
2
|
3
|
|
Overall Study
Other unspecified
|
5
|
4
|
Baseline Characteristics
A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment A - Capecitabine and Ruxolitinib
n=76 Participants
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
Treatment B - Capecitabine and Placebo
n=73 Participants
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 11.00 • n=93 Participants
|
55.0 years
STANDARD_DEVIATION 12.75 • n=4 Participants
|
54.6 years
STANDARD_DEVIATION 11.85 • n=27 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
149 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.Population: The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.
Overall survival is reported here by the number of days from randomization to death until the data cutoff for the final analysis. The hazard ratio (80% CI) for ruxolitinib versus placebo was estimated using a Cox regression model stratified by hormone-receptor status.
Outcome measures
| Measure |
Treatment A - Capecitabine and Ruxolitinib
n=76 Participants
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
Treatment B - Capecitabine and Placebo
n=73 Participants
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
|---|---|---|
|
Overall Survival (OS)
Death events
|
39 Participants
|
38 Participants
|
|
Overall Survival (OS)
Censored events
|
37 Participants
|
35 Participants
|
PRIMARY outcome
Timeframe: Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.Population: The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.
Survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment A - Capecitabine and Ruxolitinib
n=76 Participants
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
Treatment B - Capecitabine and Placebo
n=73 Participants
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
|---|---|---|
|
Median Survival
|
11.2 months
Interval 7.5 to 12.7
|
10.9 months
Interval 6.0 to 13.1
|
PRIMARY outcome
Timeframe: Randomization until death due to any cause at month 3, 6, 9, 12 and 15 or the data cutoff 08FEB2016.Population: The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.
Overall survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment A - Capecitabine and Ruxolitinib
n=76 Participants
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
Treatment B - Capecitabine and Placebo
n=73 Participants
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
|---|---|---|
|
Percentage of Participants Achieving Overall Survival
Month 3 Survival Rate
|
0.855 percentage of participants
Interval 0.753 to 0.917
|
0.750 percentage of participants
Interval 0.633 to 0.835
|
|
Percentage of Participants Achieving Overall Survival
Month 6 Survival Rate
|
0.674 percentage of participants
Interval 0.554 to 0.769
|
0.635 percentage of participants
Interval 0.511 to 0.735
|
|
Percentage of Participants Achieving Overall Survival
Month 9 Survival Rate
|
0.537 percentage of participants
Interval 0.404 to 0.652
|
0.546 percentage of participants
Interval 0.417 to 0.657
|
|
Percentage of Participants Achieving Overall Survival
Month 12 Survival Rate
|
0.435 percentage of participants
Interval 0.289 to 0.573
|
0.427 percentage of participants
Interval 0.286 to 0.561
|
|
Percentage of Participants Achieving Overall Survival
Month 15 Survival Rate
|
0.319 percentage of participants
Interval 0.174 to 0.475
|
0.294 percentage of participants
Interval 0.148 to 0.456
|
SECONDARY outcome
Timeframe: Randomization to disease progression, or death due to any cause if sooner up to 19 months or the data cutoff 08FEB2016.Population: The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.
Progression-free survival was defined as the time from the randomization date to the earliest date of disease progression, as measured by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death from any cause if earlier. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment A - Capecitabine and Ruxolitinib
n=76 Participants
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
Treatment B - Capecitabine and Placebo
n=73 Participants
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
|---|---|---|
|
Progression-free Survival (PFS)
|
4.5 months
Interval 2.3 to 6.1
|
2.5 months
Interval 2.1 to 4.1
|
SECONDARY outcome
Timeframe: Randomization through end of study up to 19 months or the data cutoff 08FEB2016.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 |
Treatment A - Capecitabine and Ruxolitinib
n=76 Participants
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
Treatment B - Capecitabine and Placebo
n=73 Participants
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
|---|---|---|
|
Percentage of Participants Achieving Objective Response Rate
Complete Response rate
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Achieving Objective Response Rate
Partial Response rate
|
28.9 percentage of participants
|
13.7 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization through end of study up to 19 months or the data cutoff 08FEB2016.Population: The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.
The DOR was defined as the difference (in number of months) between the end of response and the start of response for participants who had at least 1 response measurement. The start of a response was the first visit where the participant achieved a partial response or better based on RECIST (v1.1) criteria. The end of response was the earlier of death or progressive disease based on RECIST (v1.1) criteria. The date of progressive disease was the date on which progression was first recorded. 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 |
Treatment A - Capecitabine and Ruxolitinib
n=76 Participants
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
Treatment B - Capecitabine and Placebo
n=73 Participants
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
|---|---|---|
|
Duration of Response (DOR)
|
4.2 months
Interval 3.5 to 4.6
|
4.4 months
Interval 3.8 to 6.4
|
SECONDARY outcome
Timeframe: Randomization through end of study up to 19 months or the data cutoff 08FEB2016.Population: The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.
Clinical benefit rate was defined as a complete response, partial response, or stable disease, determined by investigator assessment of objective radiographic disease assessments per RECIST (v1.1) that lasted for ≥ 6 months. 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 |
Treatment A - Capecitabine and Ruxolitinib
n=76 Participants
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
Treatment B - Capecitabine and Placebo
n=73 Participants
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
|---|---|---|
|
Percentage of Participants Achieving Clinical Benefit Rate
|
13.2 percentage of participants
|
6.8 percentage of participants
|
Adverse Events
Treatment A - Capecitabine and Ruxolitinib
Serious events: 28 serious events
Other events: 69 other events
Deaths: 0 deaths
Treatment B - Capecitabine and Placebo
Serious events: 29 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment A - Capecitabine and Ruxolitinib
n=71 participants at risk
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
Treatment B - Capecitabine and Placebo
n=71 participants at risk
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Cardiac disorders
Cardiac failure
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Cardiac disorders
Tachycardia
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Colitis
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Nausea
|
7.0%
5/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Stomatitis
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
General disorders
Non-cardiac chest pain
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
General disorders
Oedema
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
General disorders
Pain
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
General disorders
Pyrexia
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Hepatobiliary disorders
Hepatic failure
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Infections and infestations
Bronchitis
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Infections and infestations
Clostridium difficile infection
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Infections and infestations
Lung infection
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Infections and infestations
Pneumonia
|
4.2%
3/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Infections and infestations
Sepsis
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Infections and infestations
Urinary tract infection
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Investigations
Blood creatinine increased
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Investigations
Platelet count decreased
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
3/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Nervous system disorders
Headache
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Nervous system disorders
Syncope
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Psychiatric disorders
Confusional state
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Renal and urinary disorders
Hydronephrosis
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Renal and urinary disorders
Renal failure acute
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.2%
3/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.2%
3/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
8.5%
6/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
4.2%
3/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Vascular disorders
Embolism
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Vascular disorders
Hypertension
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
Other adverse events
| Measure |
Treatment A - Capecitabine and Ruxolitinib
n=71 participants at risk
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
Treatment B - Capecitabine and Placebo
n=71 participants at risk
Capecitabine given as 1000 mg/m\^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
49.3%
35/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
25.4%
18/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.7%
9/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
7.0%
5/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.5%
6/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Cardiac disorders
Tachycardia
|
8.5%
6/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
4.2%
3/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.0%
5/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
8.5%
6/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.9%
12/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
8.5%
6/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Constipation
|
25.4%
18/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
23.9%
17/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Diarrhoea
|
46.5%
33/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
26.8%
19/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.5%
6/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Nausea
|
54.9%
39/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
49.3%
35/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Stomatitis
|
26.8%
19/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
16.9%
12/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Gastrointestinal disorders
Vomiting
|
36.6%
26/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
26.8%
19/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
General disorders
Fatigue
|
56.3%
40/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
43.7%
31/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
General disorders
Oedema
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
4.2%
3/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
General disorders
Pyrexia
|
16.9%
12/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
14.1%
10/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
General disorders
Oedema peripheral
|
14.1%
10/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
19.7%
14/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Infections and infestations
Urinary tract infection
|
8.5%
6/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
8.5%
6/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Investigations
Alanine aminotransferase increased
|
8.5%
6/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Investigations
Aspartate aminotransferase increased
|
12.7%
9/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
7.0%
5/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.0%
5/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Investigations
Blood creatinine increased
|
7.0%
5/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
4.2%
3/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Investigations
Lymphocyte count decreased
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Investigations
Neutrophil count decreased
|
8.5%
6/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Investigations
Platelet count decreased
|
8.5%
6/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Investigations
Weight decreased
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
7.0%
5/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Investigations
Weight increased
|
8.5%
6/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Investigations
White blood cell count decreased
|
9.9%
7/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
29.6%
21/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
26.8%
19/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Metabolism and nutrition disorders
Dehydration
|
15.5%
11/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
4.2%
3/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.3%
8/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.1%
10/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
7.0%
5/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.9%
7/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
12.7%
9/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.5%
11/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
7.0%
5/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.0%
5/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
4.2%
3/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.0%
5/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.2%
3/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
7.0%
5/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
7.0%
5/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.0%
5/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.7%
9/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
7.0%
5/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Nervous system disorders
Dizziness
|
18.3%
13/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
18.3%
13/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Nervous system disorders
Dysgeusia
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
7.0%
5/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Nervous system disorders
Headache
|
22.5%
16/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
12.7%
9/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Nervous system disorders
Hypoaesthesia
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Nervous system disorders
Neuropathy peripheral
|
4.2%
3/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
7.0%
5/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
7.0%
5/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Psychiatric disorders
Anxiety
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
8.5%
6/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Psychiatric disorders
Insomnia
|
11.3%
8/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
12.7%
9/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.7%
14/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
12.7%
9/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
31.0%
22/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
28.2%
20/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.0%
5/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
0.00%
0/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.2%
3/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
7.0%
5/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
46.5%
33/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
38.0%
27/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
8.5%
6/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Vascular disorders
Hot flush
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
1.4%
1/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
|
Vascular disorders
Hypertension
|
5.6%
4/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
2.8%
2/71 • Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine). Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.
|
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