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Trial Outcomes & Findings for Study of Ruxolitinib in Pancreatic Cancer Patients (NCT NCT01423604)

NCT ID: NCT01423604

Last Updated: 2018-02-12

Results Overview

Overall survival was measured as the length of time (in days) between the randomization date and the date of death.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

136 participants

Primary outcome timeframe

Primary analysis includes study data from the start of the study (first dose for that subject) until the death of the subject (up to 8 months).

Results posted on

2018-02-12

Participant Flow

The open-label, safety run-in (1 cohort) was designed to confirm the safety of the combination of ruxolitinib and capecitabine in subjects with advanced or metastatic adenocarcinoma of the pancreas. The double-blind portion was 2 treatment groups randomized 1:1: ruxolitinib plus capecitabine or matching placebo plus capecitabine.

Participant milestones

Participant milestones
Measure
Ruxolitinib
Part 1: Subjects received capecitabine 2000 mg/m\^2 (1000 mg/m\^2 twice a day (BID)) + ruxolitinib 15 mg BID. Part 2: Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]).
Placebo
Part 2: Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]).
Safety Run-In
STARTED
9
0
Safety Run-In
COMPLETED
0
0
Safety Run-In
NOT COMPLETED
9
0
Randomized
STARTED
64
63
Randomized
COMPLETED
1
0
Randomized
NOT COMPLETED
63
63

Reasons for withdrawal

Reasons for withdrawal
Measure
Ruxolitinib
Part 1: Subjects received capecitabine 2000 mg/m\^2 (1000 mg/m\^2 twice a day (BID)) + ruxolitinib 15 mg BID. Part 2: Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]).
Placebo
Part 2: Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]).
Safety Run-In
Adverse Event
3
0
Safety Run-In
Death
1
0
Safety Run-In
Physician Decision
1
0
Safety Run-In
Disease progression
3
0
Safety Run-In
Patient decision
1
0
Randomized
Adverse Event
4
10
Randomized
Death
1
0
Randomized
Physician Decision
16
13
Randomized
Other - unspecified
37
31
Randomized
Patient decision
5
9

Baseline Characteristics

Study of Ruxolitinib in Pancreatic Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ruxolitinib - Safety Run-In
n=9 Participants
Subjects received capecitabine 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]) + ruxolitinib at 15 mg BID.
Ruxolitinib
n=64 Participants
Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]).
Placebo
n=63 Participants
Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]).
Total
n=136 Participants
Total of all reporting groups
Age, Continuous
61.6 years
STANDARD_DEVIATION 9.4 • n=99 Participants
65.7 years
STANDARD_DEVIATION 9.3 • n=107 Participants
66.3 years
STANDARD_DEVIATION 9.8 • n=206 Participants
66.0 years
STANDARD_DEVIATION 9.5 • n=7 Participants
Sex: Female, Male
Female
5 Participants
n=99 Participants
23 Participants
n=107 Participants
29 Participants
n=206 Participants
57 Participants
n=7 Participants
Sex: Female, Male
Male
4 Participants
n=99 Participants
41 Participants
n=107 Participants
34 Participants
n=206 Participants
79 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
1 Participants
n=107 Participants
5 Participants
n=206 Participants
6 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants
n=99 Participants
62 Participants
n=107 Participants
58 Participants
n=206 Participants
129 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
1 Participants
n=7 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Asian
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
2 Participants
n=7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=99 Participants
9 Participants
n=107 Participants
6 Participants
n=206 Participants
18 Participants
n=7 Participants
Race (NIH/OMB)
White
5 Participants
n=99 Participants
54 Participants
n=107 Participants
54 Participants
n=206 Participants
113 Participants
n=7 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
3 Participants
n=7 Participants
Height
171.67 cm
STANDARD_DEVIATION 14.11 • n=99 Participants
171.29 cm
STANDARD_DEVIATION 11.93 • n=107 Participants
168.27 cm
STANDARD_DEVIATION 10.25 • n=206 Participants
169.78 cm
STANDARD_DEVIATION 11.18 • n=7 Participants
Weight
75.051 kg
STANDARD_DEVIATION 17.317 • n=99 Participants
75.014 kg
STANDARD_DEVIATION 21.914 • n=107 Participants
69.299 kg
STANDARD_DEVIATION 16.260 • n=206 Participants
72.156 kg
STANDARD_DEVIATION 19.427 • n=7 Participants
Body mass index (BMI)
25.3 kg/m^2
STANDARD_DEVIATION 4.209 • n=99 Participants
25.354 kg/m^2
STANDARD_DEVIATION 6.332 • n=107 Participants
24.243 kg/m^2
STANDARD_DEVIATION 4.237 • n=206 Participants
24.789 kg/m^2
STANDARD_DEVIATION 5.394 • n=7 Participants
Body surface area
1.869 m^2
STANDARD_DEVIATION 0.287 • n=99 Participants
1.863 m^2
STANDARD_DEVIATION 0.297 • n=107 Participants
1.791 m^2
STANDARD_DEVIATION 0.248 • n=206 Participants
1.827 m^2
STANDARD_DEVIATION 0.275 • n=7 Participants

PRIMARY outcome

Timeframe: Primary analysis includes study data from the start of the study (first dose for that subject) until the death of the subject (up to 8 months).

Population: The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.

Overall survival was measured as the length of time (in days) between the randomization date and the date of death.

Outcome measures

Outcome measures
Measure
Ruxolitinib
n=64 Participants
Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]).
Placebo
n=63 Participants
Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]).
Overall Survival
136.5 days
Interval 95.0 to 196.0
129.5 days
Interval 71.0 to 179.0

SECONDARY outcome

Timeframe: Analysis includes study data from the start of the study (first dose for that subject) until death or PD, whichever was earlier up to 8 months.

Population: The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.

Progression-free survival was defined as the length of time between the date of randomization and the earlier of death or progressive disease (PD), whichever was earlier, as assessed by RECIST. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure
Ruxolitinib
n=64 Participants
Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]).
Placebo
n=63 Participants
Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]).
Progression-Free Survival (PFS)
51.0 days
Interval 42.0 to 84.0
46.0 days
Interval 41.0 to 70.0

SECONDARY outcome

Timeframe: Measured every 4 weeks for duration of study treatment (up to 8 months)

Population: The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.

Objective response rate (ORR) was defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) measured by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria during the treatment period. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure
Ruxolitinib
n=64 Participants
Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]).
Placebo
n=63 Participants
Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]).
Objective Response Rate
Overall response
7.8 percentage of participants
1.6 percentage of participants
Objective Response Rate
Complete response
1.6 percentage of participants
0.0 percentage of participants
Objective Response Rate
Partial response
6.3 percentage of participants
1.6 percentage of participants

SECONDARY outcome

Timeframe: Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)

Population: The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.

Durable response was defined as subjects with a response of Partial response (PR) or better at 2 subsequent measurements that were at least 4 weeks apart.

Outcome measures

Outcome measures
Measure
Ruxolitinib
n=64 Participants
Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]).
Placebo
n=63 Participants
Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]).
Durable Response Rate
7.8 percentage of participants
0.0 percentage of participants

SECONDARY outcome

Timeframe: Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)

Population: The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.

A subject was considered a clinical benefit responder if he/she met at least 1 of the following criteria: 1. Subject showed improvement in at least one of the following parameters on successive scheduled observations without worsening in the others: pain intensity, analgesic use, or performance status 2. Subject was stable or improved on the pain intensity, analgesic use, and performance status and had a ≥ 7% increase in body weight maintained for 2 consecutive reporting periods that was not because of fluid accumulation.

Outcome measures

Outcome measures
Measure
Ruxolitinib
n=64 Participants
Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]).
Placebo
n=63 Participants
Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]).
Summary of Clinical Benefit
Subjects with clinical benefit
12.5 percentage of participants
1.6 percentage of participants
Summary of Clinical Benefit
Pain intensity - Improved
10.9 percentage of participants
1.6 percentage of participants
Summary of Clinical Benefit
Analgesic use - Improved
4.7 percentage of participants
0.0 percentage of participants
Summary of Clinical Benefit
Karnofsky performance status - Improved
3.1 percentage of participants
0.0 percentage of participants
Summary of Clinical Benefit
Body weight - Improved
3.1 percentage of participants
0.0 percentage of participants

Adverse Events

Ruxolitinib (Safety Run-In)

Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths

Ruxolitinib

Serious events: 32 serious events
Other events: 57 other events
Deaths: 0 deaths

Placebo

Serious events: 35 serious events
Other events: 59 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Ruxolitinib (Safety Run-In)
n=9 participants at risk
Subjects received capecitabine 2000 mg/m\^2 daily (taken as 1000 mg/m2 twice daily \[BID\]) + ruxolitinib 15 mg BID
Ruxolitinib
n=59 participants at risk
Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]).
Placebo
n=60 participants at risk
Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]).
Blood and lymphatic system disorders
Anemia
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
6.8%
4/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Cardiac disorders
Acute myocardial infarction
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Cardiac disorders
Cardiorespiratory arrest
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Cardiac disorders
Atrial fibrillation
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Cardiac disorders
Myocardial infarction
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Eye disorders
Diplopia
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Abdominal pain
22.2%
2/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.4%
2/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
8.3%
5/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Diarrhoea
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.4%
2/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Large intestinal obstruction
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.4%
2/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Nausea
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.4%
2/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
8.3%
5/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Ascites
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.3%
2/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Colitis
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Colonic obstruction
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Constipation
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Enteritis
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Esophagitis
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Intestinal perforation
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Obstruction gastric
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.0%
3/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Pancreatitis
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Rectal hemorrhage
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Vomiting
22.2%
2/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
8.3%
5/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Abdominal distension
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Esophageal varices hemorrhage
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Fecaloma
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Hematemesis
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Necrotizing colitis
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
General disorders
Performance status decreased
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.4%
2/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
General disorders
Pyrexia
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.4%
2/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
General disorders
Asthenia
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.3%
2/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
General disorders
Device occlusion
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
General disorders
Fatigue
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
General disorders
General physical health deterioration
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
General disorders
Pain
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Hepatobiliary disorders
Bile duct obstruction
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Hepatobiliary disorders
Cholangitis
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Hepatobiliary disorders
Jaundice
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Pneumonia
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
8.5%
5/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Cellulitis
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Diverticulitis
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Empyema
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Klebsiella bacteremia
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Sepsis
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Bacteremia
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
6.7%
4/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Pneumonia klebsiella
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Septic shock
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Urinary tract infection
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Injury, poisoning and procedural complications
Hip fracture
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Investigations
International normalized ratio increased
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Dehydration
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.1%
3/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.3%
2/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Hypoglycemia
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Hyponatremia
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Diabetic ketoacidosis
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Failure to thrive
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Nervous system disorders
Depressed level of consciousness
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Nervous system disorders
Somnolence
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Nervous system disorders
Syncope
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Nervous system disorders
Transient ischemic attack
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Nervous system disorders
Cerebrovascular accident
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Psychiatric disorders
Confusional state
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Psychiatric disorders
Mental status changes
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Renal and urinary disorders
Renal failure acute
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Renal and urinary disorders
Renal failure
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders
Dyspnea
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.3%
2/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Surgical and medical procedures
Colostomy
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Vascular disorders
Hypotension
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.3%
2/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Vascular disorders
Peripheral arterial occlusive disease
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Gastrointestinal Haemorrhage
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Intestinal Obstruction
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Staphylococcal Sepsis
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Streptococcal Sepsis
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Investigations
Prothrombin Time Prolonged
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Nervous system disorders
Convulsion
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
General disorders
Mucosal Inflammation
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Vascular disorders
Shock Haemorrhagic
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure
Ruxolitinib (Safety Run-In)
n=9 participants at risk
Subjects received capecitabine 2000 mg/m\^2 daily (taken as 1000 mg/m2 twice daily \[BID\]) + ruxolitinib 15 mg BID
Ruxolitinib
n=59 participants at risk
Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]).
Placebo
n=60 participants at risk
Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m\^2 (1000 mg/m\^2 twice a day \[BID\]).
Blood and lymphatic system disorders
Anemia
77.8%
7/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
50.8%
30/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
20.0%
12/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
General disorders
Fatigue
22.2%
2/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
49.2%
29/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
43.3%
26/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Abdominal pain
55.6%
5/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
37.3%
22/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
38.3%
23/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Diarrhea
44.4%
4/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
37.3%
22/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
28.3%
17/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Nausea
44.4%
4/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
35.6%
21/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
45.0%
27/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
22.2%
2/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
32.2%
19/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
31.7%
19/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Stomatitis
33.3%
3/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
27.1%
16/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
13.3%
8/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Vomiting
55.6%
5/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
23.7%
14/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
35.0%
21/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Decreased appetite
22.2%
2/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
20.3%
12/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
33.3%
20/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Dehydration
55.6%
5/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
20.3%
12/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
16.7%
10/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Constipation
22.2%
2/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
18.6%
11/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
31.7%
19/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
General disorders
Pyrexia
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
16.9%
10/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
8.3%
5/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders
Back pain
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
13.6%
8/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
20.0%
12/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
General disorders
Asthenia
22.2%
2/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
11.9%
7/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
13.3%
8/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Nervous system disorders
Dizziness
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
11.9%
7/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
8.3%
5/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Edema peripheral
33.3%
3/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
11.9%
7/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
10.0%
6/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Flatulence
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
11.9%
7/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.0%
3/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
11.9%
7/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.0%
3/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Abdominal pain upper
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
10.2%
6/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
11.7%
7/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Ascites
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
10.2%
6/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
16.7%
10/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Hyponatremia
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
10.2%
6/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.3%
2/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Vascular disorders
Hypotension
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
10.2%
6/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.3%
2/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
10.2%
6/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.0%
3/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Pneumonia
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
10.2%
6/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.0%
3/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
General disorders
Chills
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
8.5%
5/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.3%
2/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Psychiatric disorders
Confusional state
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
8.5%
5/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.0%
3/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders
Dyspnea
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
8.5%
5/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
18.3%
11/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
8.5%
5/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.0%
3/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Investigations
Weight decreased
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
8.5%
5/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.0%
3/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Investigations
Aspartate aminotransferase increased
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
6.8%
4/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Investigations
Blood alkaline phosphatase increased
22.2%
2/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
6.8%
4/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.0%
3/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Injury, poisoning and procedural complications
Contusion
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
6.8%
4/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.0%
3/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders
Cough
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
6.8%
4/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
6.7%
4/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Edema
22.2%
2/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
6.8%
4/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.3%
2/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Hyperglycemia
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
6.8%
4/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
8.3%
5/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
6.8%
4/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Nervous system disorders
Neuropathy peripheral
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
6.8%
4/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.0%
3/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Candidiasis
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.1%
3/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
6.7%
4/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Psychiatric disorders
Depression
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.1%
3/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
10.0%
6/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.1%
3/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Nervous system disorders
Dysgeusia
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.1%
3/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Vascular disorders
Hemorrhoids
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.1%
3/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Hypokalemia
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.1%
3/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.3%
2/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Psychiatric disorders
Insomnia
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.1%
3/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
11.7%
7/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Investigations
International normalized ratio increased
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.1%
3/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
6.7%
4/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Blood and lymphatic system disorders
Leukopenia
33.3%
3/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.1%
3/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.3%
2/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders
Muscle spasms
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.1%
3/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Blood and lymphatic system disorders
Neutropenia
22.2%
2/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.1%
3/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.0%
3/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.1%
3/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.0%
3/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Psychiatric disorders
Somnolence
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.1%
3/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.4%
2/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.0%
3/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders
Arthralgia
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.4%
2/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
11.7%
7/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Dyspepsia
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.4%
2/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
10.0%
6/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Gastroesophageal reflux disease
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.4%
2/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
8.3%
5/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Nervous system disorders
Headache
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.4%
2/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
6.7%
4/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.4%
2/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.0%
3/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Renal and urinary disorders
Urinary tract infection
22.2%
2/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
3.4%
2/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
11.7%
7/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Abdominal distension
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.0%
3/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Obstruction gastric
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.0%
3/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
8.3%
5/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
1.7%
1/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.0%
3/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Bacteremia
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
6.7%
4/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Investigations
Platelet count decreased
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
6.7%
4/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders
Rash maculopapular
0.00%
0/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
5.0%
3/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Blood and lymphatic system disorders
Leukocytosis
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Eye disorders
Dry eye
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Dysphagia
22.2%
2/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Dry mouth
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Food poisoning
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Gastrointestinal haemorrhage
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Intestinal obstruction
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Gastrointestinal disorders
Tongue pigmentation
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
General disorders
Catheter site discharge
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
General disorders
Catheter site pain
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
General disorders
Chest pain
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
General disorders
Mucosal Inflammation
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
General disorders
Pain
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
General disorders
Suprapubic pain
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
General disorders
Temperature Intolerance
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
General disorders
Tenderness
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Hepatobiliary disorders
Portal Vein Thrombosis
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Bronchitis
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Cellulitis
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Nail Bed Infection
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Onychomycosis
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Oral Candidiasis
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Rhinitis
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Vascular disorders
Orthostatic Hypotension
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Vascular disorders
Shock Haemorrhagic
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Sepsis
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Staphylococcal Sepsis
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Infections and infestations
Streptococcal Sepsis
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Injury, poisoning and procedural complications
Open Wound
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Investigations
Prothrombin Time Prolonged
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Hypokalaemia
33.3%
3/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Failure to Thrive
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Hypoalbuminaemia
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Hypocalcaemia
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Hypomagnesaemia
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Hypophagia
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Hypophosphataemia
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Hypoproteinaemia
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Metabolism and nutrition disorders
Malnutrition
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Nervous system disorders
Cerebrovascular Accident
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Nervous system disorders
Convulsion
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Psychiatric disorders
Mental Status Changes
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Reproductive system and breast disorders
Testicular Oedema
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders
Pleurisy
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Irritation
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders
Blister
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders
Onycholysis
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders
Skin Discolouration
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders
Skin Exfoliation
11.1%
1/9 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/59 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
0.00%
0/60 • From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.

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