Trial Outcomes & Findings for An Open-Label Study of Ruxolitinib Given With Chemotherapy in Patients With Advanced Solid Tumors (NCT NCT01822756)
NCT ID: NCT01822756
Last Updated: 2018-02-12
Results Overview
Toxicities occurring during the first treatment cycle (Cycle 1) defined tolerability. Within each cohort, subjects were considered evaluable if they had received at least 40 of 56 planned doses of RUX during the 28-day surveillance period and received 2 of the 3 planned doses of chemotherapy (gemcitabine and/or gemcitabine and nab-paclitaxel) at the assigned dose level, or they had experienced a DLT.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
Approximately 28 days
Results posted on
2018-02-12
Participant Flow
Participant milestones
| Measure |
Cohort A0
RUX 15 mg BID; Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15
|
Cohort B (-1)
RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15; + GCSF
|
Cohort B0 (+GCSF)
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; +GCSF
|
Cohort B0 (-GCSF)
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; -GCSF
|
Cohort B1
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
4
|
10
|
4
|
8
|
|
Overall Study
Discontinued From the Study
|
16
|
4
|
10
|
4
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
16
|
4
|
10
|
4
|
7
|
Reasons for withdrawal
| Measure |
Cohort A0
RUX 15 mg BID; Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15
|
Cohort B (-1)
RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15; + GCSF
|
Cohort B0 (+GCSF)
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; +GCSF
|
Cohort B0 (-GCSF)
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; -GCSF
|
Cohort B1
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Disease progression
|
11
|
1
|
7
|
2
|
6
|
|
Overall Study
Death
|
2
|
2
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
disease progression & patient preference
|
2
|
0
|
1
|
0
|
0
|
Baseline Characteristics
An Open-Label Study of Ruxolitinib Given With Chemotherapy in Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Cohort A0
n=16 Participants
RUX 15 mg BID; Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15
|
Cohort B (-1)
n=4 Participants
RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15; + GCSF
|
Cohort B0 (+GCSF)
n=10 Participants
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; +GCSF
|
Cohort B0 (-GCSF)
n=4 Participants
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; -GCSF
|
Cohort B1
n=8 Participants
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 8.56 • n=99 Participants
|
61.3 years
STANDARD_DEVIATION 6.40 • n=107 Participants
|
61.2 years
STANDARD_DEVIATION 9.33 • n=206 Participants
|
70.0 years
STANDARD_DEVIATION 7.62 • n=7 Participants
|
62.4 years
STANDARD_DEVIATION 8.48 • n=31 Participants
|
62.8 years
STANDARD_DEVIATION 8.45 • n=30 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
20 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
22 Participants
n=30 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
0
|
6 participants
n=99 Participants
|
2 participants
n=107 Participants
|
8 participants
n=206 Participants
|
3 participants
n=7 Participants
|
5 participants
n=31 Participants
|
24 participants
n=30 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
1
|
10 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
1 participants
n=7 Participants
|
3 participants
n=31 Participants
|
18 participants
n=30 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
2
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Approximately 28 daysPopulation: Safety population included all enrolled subjects who received at least 1 dose of RUX.
Toxicities occurring during the first treatment cycle (Cycle 1) defined tolerability. Within each cohort, subjects were considered evaluable if they had received at least 40 of 56 planned doses of RUX during the 28-day surveillance period and received 2 of the 3 planned doses of chemotherapy (gemcitabine and/or gemcitabine and nab-paclitaxel) at the assigned dose level, or they had experienced a DLT.
Outcome measures
| Measure |
Cohort A0
n=16 Participants
RUX 15 mg BID; Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15
|
Cohort B (-1)
n=4 Participants
RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15; + GCSF
|
Cohort B0 (+GCSF)
n=10 Participants
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; +GCSF
|
Cohort B0 (-GCSF)
n=4 Participants
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; -GCSF
|
Cohort B1
n=8 Participants
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
|
|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events That Are Defined as Dose Limiting Toxicities (DLTs)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
20.0 percentage of participants
|
50.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 and Day 8Population: Further enrollment of additional study cohorts was stopped after Cohort B1, RUX 10 mg BID - GCSF; Part 2 of the study was not conducted. Because of the early study termination, samples for pharmacokinetics and pharmacodynamics, and computed tomography for tumor burden were collected, but not analyzed; analysis data are not available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Enrollment of additional study cohorts was stopped after Cohort B1, RUX 10 mg BID-GCSF; Part 2 of the study was not conducted.Because of the early study termination, samples for pharmacokinetics and pharmacodynamics, and computed tomography for tumor burden were collected, but not analyzed; analysis data are not available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 6 monthsPopulation: Enrollment of additional study cohorts was stopped after Cohort B1, RUX 10 mg BID-GCSF; Part 2 of the study was not conducted. Because of the early study termination, samples for pharmacokinetics and pharmacodynamics, and computed tomography for tumor burden were collected, but not analyzed; analysis data are not available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: every 2 cycles starting at Cycle 3 Day 1 up to approximately 4 to 6 monthsPopulation: Intent-to-Treat (ITT) Population - All subjects who received at least 1 dose of RUX
Best response was determined on the subject level using the highest overall response achieved post-baseline. In the case of stable disease (SD), measurements had to meet the SD criterion at least once after study entry at a minimum interval of 49 days. Subjects who failed to meet this criterion had best response of progressive disease (PD) if the next available RECIST evaluation after the initial scan indicated PD or not evaluable (NE) if no additional RECIST evaluations were available. Complete Response (CR) and Partial Response (PR) defined by the Response Evaluation Criteria in Solid Tumor (RECIST) criteria. CR: Disappearance of all target and nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, or persistence of 1 or more nontarget lesion(s) or/and maintenance of tumor marker level above the normal limits.
Outcome measures
| Measure |
Cohort A0
n=16 Participants
RUX 15 mg BID; Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15
|
Cohort B (-1)
n=4 Participants
RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15; + GCSF
|
Cohort B0 (+GCSF)
n=10 Participants
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; +GCSF
|
Cohort B0 (-GCSF)
n=4 Participants
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; -GCSF
|
Cohort B1
n=8 Participants
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
|
|---|---|---|---|---|---|
|
Percentage of Participants With a Best Response by RECIST Criteria
Overall response
|
12.5 percentage of participants
|
25.0 percentage of participants
|
50.0 percentage of participants
|
25.0 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With a Best Response by RECIST Criteria
Complete response
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
25.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Best Response by RECIST Criteria
Partial response
|
12.5 percentage of participants
|
25.0 percentage of participants
|
50.0 percentage of participants
|
0.0 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With a Best Response by RECIST Criteria
Stable disease
|
25.0 percentage of participants
|
75.0 percentage of participants
|
20.0 percentage of participants
|
50.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With a Best Response by RECIST Criteria
Progressive disease
|
37.5 percentage of participants
|
0.0 percentage of participants
|
10.0 percentage of participants
|
0.0 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With a Best Response by RECIST Criteria
Not evaluable
|
6.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Best Response by RECIST Criteria
Missing
|
18.8 percentage of participants
|
0.0 percentage of participants
|
20.0 percentage of participants
|
25.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization to clinical cutoff 22Sept2015 (approx 244 days)Population: Intent-to-Treat Population (ITT) population - All subjects who received at least 1 dose of RUX
Duration of response was measured as the time from the first overall response contributing to an objective response to the first overall response of progressive disease (PD) occurring after the first overall response contributing to the objective response.
Outcome measures
| Measure |
Cohort A0
n=16 Participants
RUX 15 mg BID; Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15
|
Cohort B (-1)
n=4 Participants
RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15; + GCSF
|
Cohort B0 (+GCSF)
n=10 Participants
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; +GCSF
|
Cohort B0 (-GCSF)
n=4 Participants
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; -GCSF
|
Cohort B1
n=8 Participants
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
|
|---|---|---|---|---|---|
|
Percentage of Responders
|
12.5 Percentage of responders
|
25.0 Percentage of responders
|
50.0 Percentage of responders
|
25.0 Percentage of responders
|
37.5 Percentage of responders
|
SECONDARY outcome
Timeframe: Randomization to clinical cutoff 22Sept2015 (approx 244 days)Population: Intent-to-Treat Population (ITT) population - All subjects who received at least 1 dose of RUX
Duration of response was the time from the first overall response contributing to an objective response to the first overall response of progressive disease (PD) occurring after the first overall response contributing to the objective response. Confidence intervals for median duration of response were calculated using the method of Brookmeyer and Crowley (1982).
Outcome measures
| Measure |
Cohort A0
n=16 Participants
RUX 15 mg BID; Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15
|
Cohort B (-1)
n=4 Participants
RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15; + GCSF
|
Cohort B0 (+GCSF)
n=10 Participants
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; +GCSF
|
Cohort B0 (-GCSF)
n=4 Participants
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; -GCSF
|
Cohort B1
n=8 Participants
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
|
|---|---|---|---|---|---|
|
Duration of Response
|
132.0 days
Not estimated; insufficient number of participants with events.
|
33.0 days
Not estimated; insufficient number of participants with events.
|
113.0 days
Interval 57.0 to 533.0
|
244.0 days
Not estimated; insufficient number of participants with events.
|
225.0 days
Interval 57.0 to 225.0
|
Adverse Events
Cohort A0
Serious events: 10 serious events
Other events: 16 other events
Deaths: 0 deaths
Cohort B (-1)
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort B0 (+GCSF)
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort B0 (-GCSF)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort B1
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A0
n=16 participants at risk
RUX 15 mg BID; Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15
|
Cohort B (-1)
n=4 participants at risk
RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15; + GCSF
|
Cohort B0 (+GCSF)
n=10 participants at risk
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; +GCSF
|
Cohort B0 (-GCSF)
n=4 participants at risk
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; -GCSF
|
Cohort B1
n=8 participants at risk
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
4/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Duodenal ulcer hemorrhage
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
General disorders
Asthenia
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Hepatobiliary disorders
Cholangitis
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Infections and infestations
Eye infection toxoplasmal
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Infections and infestations
Bacteremia
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Infections and infestations
Clostridium difficile colitis
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Infections and infestations
Sepsis
|
12.5%
2/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Nervous system disorders
Transient ischemic attack
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
Other adverse events
| Measure |
Cohort A0
n=16 participants at risk
RUX 15 mg BID; Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15
|
Cohort B (-1)
n=4 participants at risk
RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15; + GCSF
|
Cohort B0 (+GCSF)
n=10 participants at risk
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; +GCSF
|
Cohort B0 (-GCSF)
n=4 participants at risk
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; -GCSF
|
Cohort B1
n=8 participants at risk
RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
|
|---|---|---|---|---|---|
|
General disorders
Feeling jittery
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
General disorders
Malaise
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
2/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
General disorders
Oedema peripheral
|
25.0%
4/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
75.0%
3/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
5/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
2/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
4/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
General disorders
Pyrexia
|
31.2%
5/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
40.0%
4/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Hepatobiliary disorders
Haemobilia
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Hepatobiliary disorders
Hepatic failure
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Ileus
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
4/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
75.0%
3/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
80.0%
8/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
2/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
37.5%
3/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Stomatitis
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
37.5%
3/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
2/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
5/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
General disorders
Chills
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
General disorders
Fatigue
|
62.5%
10/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
100.0%
4/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
80.0%
8/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
2/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
62.5%
5/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Infections and infestations
Sinusitis
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Abdominal pain
|
31.2%
5/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
20.0%
2/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
2/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
2/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
20.0%
2/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
18.8%
3/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Haematochezia
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Constipation
|
18.8%
3/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
2/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
20.0%
2/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
2/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
75.0%
3/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
5/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
2/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Blood and lymphatic system disorders
Anaemia
|
56.2%
9/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
2/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
60.0%
6/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
100.0%
4/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
37.5%
3/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
12.5%
2/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.8%
3/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
2/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
20.0%
2/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
75.0%
3/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
4/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
60.0%
6/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
100.0%
4/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Ear and labyrinth disorders
Vertigo
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Infections and infestations
Urinary tract infection
|
18.8%
3/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
30.0%
3/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Injury, poisoning and procedural complications
Laceration
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Injury, poisoning and procedural complications
Limb injury
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Investigations
Blood creatinine increased
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Investigations
Neutrophil count decreased
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
62.5%
5/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Investigations
Platelet count decreased
|
18.8%
3/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
2/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Investigations
White blood cell count decreased
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
4/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
2/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
20.0%
2/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
4/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.5%
2/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
2/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
31.2%
5/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
2/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Nervous system disorders
Dizziness
|
12.5%
2/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
2/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
30.0%
3/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
2/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
37.5%
3/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Nervous system disorders
Dysgeusia
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
2/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
20.0%
2/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
2/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
2/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Nervous system disorders
Hypoaesthesia
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Nervous system disorders
Myoclonus
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Nervous system disorders
Neuropathy peripheral
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
40.0%
4/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
2/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
4/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Psychiatric disorders
Delirium
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Psychiatric disorders
Mental status changes
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Renal and urinary disorders
Dysuria
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Renal and urinary disorders
Nephrolithiasis
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Renal and urinary disorders
Nocturia
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
2/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
30.0%
3/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
2/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
4/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
31.2%
5/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
20.0%
2/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
75.0%
3/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
37.5%
3/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
20.0%
2/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Vascular disorders
Deep vein thrombosis
|
18.8%
3/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
2/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Vascular disorders
Hypotension
|
12.5%
2/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
30.0%
3/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
2/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Eye disorders
Eye discharge
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Eye disorders
Eye irritation
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Eye disorders
Eye pain
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Eye disorders
Vision blurred
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
2/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Eye disorders
Visual impairment
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
37.5%
3/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
30.0%
3/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
20.0%
2/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Portal hypertensive gastropathy
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
General disorders
Asthenia
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
30.0%
3/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
General disorders
Axillary pain
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
General disorders
Catheter site rash
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
General disorders
Chest discomfort
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
General disorders
Early satiety
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
General disorders
Face oedema
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
General disorders
Gait disturbance
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
General disorders
Influenza like illness
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
General disorders
Irritability
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
General disorders
Local swelling
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
General disorders
Localised oedema
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
General disorders
Pain
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Infections and infestations
Eye infection
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Infections and infestations
Influenza
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Infections and infestations
Paronychia
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Infections and infestations
Skin infection
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Investigations
Cardiac enzymes increased
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
30.0%
3/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
20.0%
2/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Investigations
Weight decreased
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
2/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Investigations
White blood cell count increased
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
30.0%
3/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
2/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
18.8%
3/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
20.0%
2/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.2%
1/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Musculoskeletal and connective tissue disorders
Lower extremity mass
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
2/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
20.0%
2/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
75.0%
3/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Nervous system disorders
Tremor
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Psychiatric disorders
Depression
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Vascular disorders
Embolism
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Vascular disorders
Flushing
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Vascular disorders
Hot flush
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
40.0%
4/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
20.0%
2/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
75.0%
3/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
70.0%
7/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
50.0%
4/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
20.0%
2/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
25.0%
1/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
12.5%
1/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Gastrointestinal disorders
Colonic Polyp
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Investigations
Blood iron decreased
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/16 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
10.0%
1/10 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/4 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
0.00%
0/8 • From randomization to 30 days after last visit up to approximately 6 months.
Safety population included all enrolled subjects who received at least 1 dose of RUX.
|
Additional Information
Study Director
Incyte Corporation
Phone: 1-855-463-3463
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