Trial Outcomes & Findings for Study of INCB053914 in Subjects With Advanced Malignancies (NCT NCT02587598)
NCT ID: NCT02587598
Last Updated: 2021-12-08
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
97 participants
Primary outcome timeframe
Approximately 7 months
Results posted on
2021-12-08
Participant Flow
This study was conducted in 18 US centers and consisted of 4 parts: Parts 1 and 2 evaluated INCB053914 as a monotherapy, and Parts 3 and 4 evaluated INCB053914 as part of a combination therapy with select standard-of-care agents (cytarabine, azacitidine, and ruxolitinib) in participants with advanced malignancies. Note:The study was terminated early based on strategic business decisions and not due to concerns with the safety and tolerability of INCB053914.
A total of 58 participants were enrolled and treated in Parts 1 and 2 combined and were included in the safety population and the full analysis set. A total of 39 participants enrolled and treated in Parts 3 and 4 combined were included in the safety population and the full analysis set.
Participant milestones
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
INCB053914 was self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 was self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
INCB053914 was self-administered orally twice day as a 65mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 80 mg BID
INCB053914 was self-administered orally twice day as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
INCB053914 was self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
INCB053914 was self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: 50 mg twice a day + I-DAC (intermediate dose cytarabine) was administered at a dose of 1 g/m2 as an infusion as a combination therapy with INCB053914.
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg twice a day + Azacitidine was administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.
|
Part 3 and 4 - INCB053914 80 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine was administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.
|
Part 3 and 4: INCB053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg + Ruxolitinib was administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
|
Part 3 and 4: INCB053914 80 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 80 mg BID + Ruxolitinib was administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
11
|
4
|
21
|
12
|
6
|
6
|
7
|
9
|
3
|
14
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
11
|
4
|
21
|
12
|
6
|
6
|
7
|
9
|
3
|
14
|
Reasons for withdrawal
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
INCB053914 was self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 was self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
INCB053914 was self-administered orally twice day as a 65mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 80 mg BID
INCB053914 was self-administered orally twice day as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
INCB053914 was self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
INCB053914 was self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: 50 mg twice a day + I-DAC (intermediate dose cytarabine) was administered at a dose of 1 g/m2 as an infusion as a combination therapy with INCB053914.
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg twice a day + Azacitidine was administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.
|
Part 3 and 4 - INCB053914 80 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine was administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.
|
Part 3 and 4: INCB053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg + Ruxolitinib was administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
|
Part 3 and 4: INCB053914 80 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 80 mg BID + Ruxolitinib was administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
4
|
8
|
4
|
16
|
9
|
4
|
6
|
7
|
9
|
1
|
3
|
|
Overall Study
Study Terminated by the Sponsor
|
0
|
1
|
0
|
3
|
0
|
1
|
0
|
0
|
0
|
1
|
6
|
|
Overall Study
Reason for study withdrawal not specified
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
2
|
3
|
1
|
0
|
0
|
0
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Study of INCB053914 in Subjects With Advanced Malignancies
Baseline characteristics by cohort
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=4 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
n=11 Participants
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
n=4 Participants
INCB053914 will be self-administered orally twice day as a 65mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 80 mg BID
n=21 Participants
INCB053914 will be self-administered orally twice day as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
n=12 Participants
INCB053914 will be self-administered orally twice day s a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
n=6 Participants
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
n=6 Participants
Combination Treatment Group A: 50 mg BID + I-DAC (intermediate dose cytarabine) will be administered at a dose of 1 g/m2 per day as an infusion as a combination therapy with INCB053914.
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
n=7 Participants
Combination Treatment Group B: Azacitidine will be administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914 50 mg BID.
|
Part 3 and 4 - INCB053914 80 mg BID + Azacitidine
n=9 Participants
Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine will be administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.
|
Part 3 and 4: INCB053914 50 mg BID + Ruxolitinib
n=3 Participants
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib will be administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
|
Part 3 and 4: INCB053914 80 mg BID + Ruxolitinib
n=14 Participants
Combination Treatment Group C: INCB053914 80 mg + Ruxolitinib will be administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.5 Years
STANDARD_DEVIATION 14.25 • n=5 Participants
|
67.1 Years
STANDARD_DEVIATION 14.64 • n=7 Participants
|
67.3 Years
STANDARD_DEVIATION 9.18 • n=5 Participants
|
70.8 Years
STANDARD_DEVIATION 11.50 • n=4 Participants
|
76.5 Years
STANDARD_DEVIATION 7.19 • n=21 Participants
|
70.5 Years
STANDARD_DEVIATION 9.67 • n=10 Participants
|
70.8 Years
STANDARD_DEVIATION 6.46 • n=115 Participants
|
60.9 Years
STANDARD_DEVIATION 20.83 • n=24 Participants
|
72.9 Years
STANDARD_DEVIATION 6.31 • n=42 Participants
|
70.0 Years
STANDARD_DEVIATION 5.0 • n=42 Participants
|
72.6 Years
STANDARD_DEVIATION 7.48 • n=42 Participants
|
70.2 Years
STANDARD_DEVIATION 11.38 • n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
47 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
50 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
83 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
89 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Approximately 7 monthsOutcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=4 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
n=11 Participants
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
n=4 Participants
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
n=21 Participants
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
n=12 Participants
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
n=3 Participants
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
n=6 Participants
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
n=7 Participants
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
n=9 Participants
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
n=3 Participants
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
n=14 Participants
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Determination of the Safety and Tolerability of INCB053914 as Measured by the Number of Participants With Adverse Events
|
4 Participants
|
11 Participants
|
4 Participants
|
21 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
9 Participants
|
3 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Approximately 2 monthsPopulation: Part 4 was not opened for enrollment owing to combination regimen not being tolerated in Part 3.
The primary efficacy endpoint of ORR in patients with AML who received INCB053914 in combination with cytarabine in Part 4 was not assessed because Part 4 was not opened for enrollment owing to this combination regimen not being tolerated in Part 3.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Approximately 6 monthsPopulation: Part 4 was not opened for enrollment.
The primary efficacy endpoint of ORR in patients with AML who received INCB053914 plus azacitidine in Part 4 was not performed due to limited enrollment as a result of early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 monthPopulation: The PD evaluable population includes those in the safety population who have at least 1 valid PD measurements at both pre- and postdose.
Percent Inhibition of pBAD at the C1D15 trough from the pBAD at pre-dose by ex vivo cellular assay
Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=4 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
n=10 Participants
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
n=3 Participants
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
n=3 Participants
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
n=8 Participants
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
n=3 Participants
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Evaluation of Phosphorylated BCL--2 Associated Death Promoter Protein (pBAD)
|
41 Percentage of Inhibition
Interval 16.0 to 67.0
|
37 Percentage of Inhibition
Interval 17.0 to 59.0
|
68 Percentage of Inhibition
Interval 52.0 to 91.0
|
78 Percentage of Inhibition
Interval 63.0 to 104.0
|
55 Percentage of Inhibition
Interval 28.0 to 92.0
|
58 Percentage of Inhibition
Interval 34.0 to 80.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 5Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=6 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Tmax of Combination Treatment Group A INCB053914 50 mg + Cytarabine
|
1.52 h
Interval 1.0 to 2.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 5Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=6 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: AUCtau of Combination Treatment Group A INCB053914 50 mg + Cytarabine
|
2860 nM*h
Standard Deviation 2040
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 5Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=6 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Cl/F of Combination Treatment Group A INCB053914 50 mg + Cytarabine
|
122 L/hr
Standard Deviation 213
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 5Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=6 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Cmax of Combination Treatment Group A INCB053914 50 mg + Cytarabine
|
423 nM
Standard Deviation 283
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 5Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=6 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Cmin of Combination Treatment Group A INCB053914 50 mg + Cytarabine
|
139 nM
Standard Deviation 101
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=7 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Tmax of Combination Group B INCB053914 80 mg + Azatcitidine
|
2 h
Interval 1.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=7 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: AUCtau of Combination Group B INCB053914 80 mg + Azatcitidine
|
11000 nM*h
Standard Deviation 11100
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=7 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Cl/F of Combination Group B INCB053914 80 mg + Azatcitidine
|
30.8 L/h
Standard Deviation 24.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=7 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Cmax of Combination Group B INCB053914 80 mg + Azatcitidine
|
1320 nM
Standard Deviation 1240
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=7 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Cmin of Combination Group B INCB053914 80 mg + Azatcitidine
|
513 nM
Standard Deviation 431
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Regimen 2 Week 4Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=6 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Tmax of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
|
2.02 h
Interval 1.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Regimen 2 Week 4Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=6 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: AUCtau of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
|
3060 nM*h
Standard Deviation 1730
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Regimen 2 Week 4Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=6 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Cl/F of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
|
69.7 L/h
Standard Deviation 41.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Regimen 2 Week 4Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=6 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Cmax of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
|
541 nM
Standard Deviation 376
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Regimen 2 Week 4Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=6 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Cmin of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
|
104 nM
Standard Deviation 63.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=3 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
n=8 Participants
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
n=3 Participants
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
n=14 Participants
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
n=11 Participants
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
n=2 Participants
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Tmax of INCB053914 Monotherapy
|
2.0 hour
Interval 1.0 to 2.2
|
1.0 hour
Interval 0.5 to 4.0
|
2.0 hour
Interval 2.0 to 4.0
|
1.5 hour
Interval 0.5 to 4.1
|
1.0 hour
Interval 0.5 to 2.2
|
NA hour
Interval 1.0 to 1.1
Individual values presented given N=2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=3 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
n=8 Participants
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
n=3 Participants
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
n=14 Participants
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
n=11 Participants
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
n=2 Participants
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: AUCtau of INCB053914 Monotherapy
|
4140 nM*h
Standard Deviation 282
|
1290 nM*h
Standard Deviation 924
|
2480 nM*h
Standard Deviation 2470
|
3940 nM*h
Standard Deviation 3120
|
5410 nM*h
Standard Deviation 5060
|
5630 nM*h
Standard Deviation 764
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=3 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
n=8 Participants
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
n=3 Participants
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
n=14 Participants
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
n=11 Participants
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
n=2 Participants
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: CL/F of INCB053914 Monotherapy
|
47.2 L/h
Standard Deviation 3.16
|
132 L/h
Standard Deviation 132
|
95.1 L/h
Standard Deviation 73.2
|
71.2 L/h
Standard Deviation 58.5
|
85.2 L/h
Standard Deviation 114
|
39.8 L/h
Standard Deviation 293
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=3 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
n=8 Participants
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
n=3 Participants
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
n=14 Participants
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
n=11 Participants
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
n=2 Participants
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Cmax of INCB053914 Monotherapy
|
352 nM
Standard Deviation 126
|
227 nM
Standard Deviation 188
|
333 nM
Standard Deviation 276
|
591 nM
Standard Deviation 447
|
796 nM
Standard Deviation 659
|
578 nM
Standard Deviation 131
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8Population: Ctau was calculated using the predose value on C1D8
Outcome measures
| Measure |
Parts 1 and 2: INCB053914 100 mg QD
n=3 Participants
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INCB053914 50 mg BID
n=9 Participants
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 65 mg BID
n=3 Participants
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
|
Parts 1 and 2: INB053914 80 mg BID
n=14 Participants
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 100 mg BID
n=11 Participants
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
|
Parts 1 and 2: INB053914 115 mg BID
n=5 Participants
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
|
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
|
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
|
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
|
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
|
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Ctau of INCB053914 Monotherapy
|
98.2 L/h
Standard Deviation 44.9
|
65.7 L/h
Standard Deviation 44.2
|
132 L/h
Standard Deviation 148
|
213 L/h
Standard Deviation 188
|
293 L/h
Standard Deviation 322
|
410 L/h
Standard Deviation 482
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1 and 2 - INCB053914: 100 mg QD
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Part 1 and 2 - INCB053914: 50 mg BID
Serious events: 6 serious events
Other events: 11 other events
Deaths: 8 deaths
Part 1 and 2 - INCB053914: 65 mg BID
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Part 1 and 2 - INCB053914: 80 mg BID
Serious events: 6 serious events
Other events: 20 other events
Deaths: 19 deaths
Part 1 and 2 - INCB053914: 100 mg BID
Serious events: 8 serious events
Other events: 12 other events
Deaths: 9 deaths
Part 1 and 2 - INCB053914: 115 mg BID
Serious events: 5 serious events
Other events: 6 other events
Deaths: 4 deaths
Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine
Serious events: 5 serious events
Other events: 6 other events
Deaths: 6 deaths
Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine
Serious events: 5 serious events
Other events: 7 other events
Deaths: 7 deaths
Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine
Serious events: 6 serious events
Other events: 8 other events
Deaths: 9 deaths
Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib
Serious events: 5 serious events
Other events: 14 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Part 1 and 2 - INCB053914: 100 mg QD
n=4 participants at risk
Part 1 and 2 - INCB053914: 100 mg QD
|
Part 1 and 2 - INCB053914: 50 mg BID
n=11 participants at risk
Part 1 and 2 - INCB053914: 50 mg BID
|
Part 1 and 2 - INCB053914: 65 mg BID
n=4 participants at risk
Part 1 and 2 - INCB053914: 65 mg BID
|
Part 1 and 2 - INCB053914: 80 mg BID
n=21 participants at risk
Part 1 and 2 - INCB053914: 80 mg BID
|
Part 1 and 2 - INCB053914: 100 mg BID
n=12 participants at risk
Part 1 and 2 - INCB053914: 100 mg BID
|
Part 1 and 2 - INCB053914: 115 mg BID
n=6 participants at risk
Part 1 and 2 - INCB053914: 115 mg BID
|
Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine
n=6 participants at risk
Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine
|
Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine
n=7 participants at risk
Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine
|
Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine
n=9 participants at risk
Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine
|
Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib
n=3 participants at risk
Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib
|
Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib
n=14 participants at risk
Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 3 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 2 • up to approximately 6 months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Device related infection
|
25.0%
1/4 • Number of events 2 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
General disorders
Disease progression
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
9.5%
2/21 • Number of events 2 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
42.9%
3/7 • Number of events 3 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
1/4 • Number of events 2 • up to approximately 6 months
|
27.3%
3/11 • Number of events 4 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
16.7%
2/12 • Number of events 3 • up to approximately 6 months
|
33.3%
2/6 • Number of events 3 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
42.9%
3/7 • Number of events 4 • up to approximately 6 months
|
33.3%
3/9 • Number of events 3 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Vascular disorders
Haemorrhagic infarction
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Infective myositis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
General disorders
Multi-organ failure
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
General disorders
Pain
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 2 • up to approximately 6 months
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
18.2%
2/11 • Number of events 2 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
25.0%
3/12 • Number of events 3 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
General disorders
Pyrexia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
8.3%
1/12 • Number of events 2 • up to approximately 6 months
|
33.3%
2/6 • Number of events 2 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
11.1%
1/9 • Number of events 2 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
33.3%
2/6 • Number of events 2 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
27.3%
3/11 • Number of events 3 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
33.3%
2/6 • Number of events 2 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
14.3%
2/14 • Number of events 2 • up to approximately 6 months
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blast cell crisis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 2 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
33.3%
2/6 • Number of events 2 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 2 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
General disorders
Fatigue
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 2 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 3 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 2 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
General disorders
Malaise
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Infections and infestations
Otitis externa
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 2 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 4 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 3 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
Other adverse events
| Measure |
Part 1 and 2 - INCB053914: 100 mg QD
n=4 participants at risk
Part 1 and 2 - INCB053914: 100 mg QD
|
Part 1 and 2 - INCB053914: 50 mg BID
n=11 participants at risk
Part 1 and 2 - INCB053914: 50 mg BID
|
Part 1 and 2 - INCB053914: 65 mg BID
n=4 participants at risk
Part 1 and 2 - INCB053914: 65 mg BID
|
Part 1 and 2 - INCB053914: 80 mg BID
n=21 participants at risk
Part 1 and 2 - INCB053914: 80 mg BID
|
Part 1 and 2 - INCB053914: 100 mg BID
n=12 participants at risk
Part 1 and 2 - INCB053914: 100 mg BID
|
Part 1 and 2 - INCB053914: 115 mg BID
n=6 participants at risk
Part 1 and 2 - INCB053914: 115 mg BID
|
Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine
n=6 participants at risk
Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine
|
Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine
n=7 participants at risk
Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine
|
Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine
n=9 participants at risk
Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine
|
Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib
n=3 participants at risk
Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib
|
Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib
n=14 participants at risk
Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
9.5%
2/21 • Number of events 2 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
33.3%
2/6 • Number of events 2 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
22.2%
2/9 • Number of events 2 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 2 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Incision site infection
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Increased appetite
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
General disorders
Influenza like illness
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 3 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
16.7%
2/12 • Number of events 2 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Psychiatric disorders
Irritability
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Psychiatric disorders
Libido decreased
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
General disorders
Malaise
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
General disorders
Medical device complication
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
14.3%
2/14 • Number of events 2 • up to approximately 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • up to approximately 6 months
|
18.2%
2/11 • Number of events 2 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 3 • up to approximately 6 months
|
36.4%
4/11 • Number of events 6 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
19.0%
4/21 • Number of events 4 • up to approximately 6 months
|
25.0%
3/12 • Number of events 5 • up to approximately 6 months
|
33.3%
2/6 • Number of events 2 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 4 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
14.3%
2/14 • Number of events 3 • up to approximately 6 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
9.5%
2/21 • Number of events 2 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
33.3%
2/6 • Number of events 2 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
33.3%
3/9 • Number of events 7 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
16.7%
1/6 • Number of events 2 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 4 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
16.7%
1/6 • Number of events 2 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 4 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
14.3%
2/14 • Number of events 2 • up to approximately 6 months
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • up to approximately 6 months
|
18.2%
2/11 • Number of events 2 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
25.0%
3/12 • Number of events 3 • up to approximately 6 months
|
16.7%
1/6 • Number of events 2 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 4 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
21.4%
3/14 • Number of events 4 • up to approximately 6 months
|
|
Investigations
Weight decreased
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
16.7%
2/12 • Number of events 2 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
22.2%
2/9 • Number of events 2 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Investigations
White blood cell count increased
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
9.5%
2/21 • Number of events 2 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 2 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 2 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
33.3%
2/6 • Number of events 5 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
21.4%
3/14 • Number of events 3 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
19.0%
4/21 • Number of events 4 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
33.3%
2/6 • Number of events 3 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
14.3%
2/14 • Number of events 2 • up to approximately 6 months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
28.6%
2/7 • Number of events 2 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Investigations
Platelet count decreased
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
16.7%
2/12 • Number of events 3 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
33.3%
2/6 • Number of events 3 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
28.6%
4/14 • Number of events 6 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
16.7%
2/12 • Number of events 2 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 2 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
General disorders
Pyrexia
|
50.0%
2/4 • Number of events 2 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
50.0%
2/4 • Number of events 2 • up to approximately 6 months
|
9.5%
2/21 • Number of events 2 • up to approximately 6 months
|
16.7%
2/12 • Number of events 2 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
33.3%
2/6 • Number of events 3 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
33.3%
2/6 • Number of events 2 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
33.3%
2/6 • Number of events 3 • up to approximately 6 months
|
28.6%
2/7 • Number of events 2 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Cardiac disorders
Sinus tachycardia
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
33.3%
2/6 • Number of events 2 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • up to approximately 6 months
|
18.2%
2/11 • Number of events 2 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
14.3%
1/7 • Number of events 2 • up to approximately 6 months
|
44.4%
4/9 • Number of events 7 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
35.7%
5/14 • Number of events 9 • up to approximately 6 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
33.3%
2/6 • Number of events 2 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
19.0%
4/21 • Number of events 4 • up to approximately 6 months
|
25.0%
3/12 • Number of events 3 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
33.3%
3/9 • Number of events 4 • up to approximately 6 months
|
33.3%
1/3 • Number of events 1 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
16.7%
2/12 • Number of events 2 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
9.5%
2/21 • Number of events 2 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 2 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
2/4 • Number of events 2 • up to approximately 6 months
|
18.2%
2/11 • Number of events 2 • up to approximately 6 months
|
25.0%
1/4 • Number of events 2 • up to approximately 6 months
|
38.1%
8/21 • Number of events 10 • up to approximately 6 months
|
33.3%
4/12 • Number of events 5 • up to approximately 6 months
|
33.3%
2/6 • Number of events 2 • up to approximately 6 months
|
66.7%
4/6 • Number of events 4 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
44.4%
4/9 • Number of events 8 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
42.9%
6/14 • Number of events 7 • up to approximately 6 months
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
2/4 • Number of events 3 • up to approximately 6 months
|
18.2%
2/11 • Number of events 2 • up to approximately 6 months
|
75.0%
3/4 • Number of events 4 • up to approximately 6 months
|
23.8%
5/21 • Number of events 10 • up to approximately 6 months
|
41.7%
5/12 • Number of events 22 • up to approximately 6 months
|
33.3%
2/6 • Number of events 2 • up to approximately 6 months
|
50.0%
3/6 • Number of events 9 • up to approximately 6 months
|
42.9%
3/7 • Number of events 4 • up to approximately 6 months
|
33.3%
3/9 • Number of events 3 • up to approximately 6 months
|
33.3%
1/3 • Number of events 4 • up to approximately 6 months
|
35.7%
5/14 • Number of events 9 • up to approximately 6 months
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
50.0%
2/4 • Number of events 2 • up to approximately 6 months
|
9.5%
2/21 • Number of events 2 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 3 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
14.3%
2/14 • Number of events 3 • up to approximately 6 months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 2 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
2/4 • Number of events 2 • up to approximately 6 months
|
18.2%
2/11 • Number of events 3 • up to approximately 6 months
|
25.0%
1/4 • Number of events 2 • up to approximately 6 months
|
33.3%
7/21 • Number of events 9 • up to approximately 6 months
|
33.3%
4/12 • Number of events 5 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
50.0%
3/6 • Number of events 3 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
44.4%
4/9 • Number of events 6 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
42.9%
6/14 • Number of events 8 • up to approximately 6 months
|
|
General disorders
Asthenia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
16.7%
2/12 • Number of events 2 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
33.3%
2/6 • Number of events 2 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • up to approximately 6 months
|
18.2%
2/11 • Number of events 3 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
33.3%
3/9 • Number of events 3 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
19.0%
4/21 • Number of events 4 • up to approximately 6 months
|
33.3%
4/12 • Number of events 5 • up to approximately 6 months
|
33.3%
2/6 • Number of events 3 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 2 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
9.5%
2/21 • Number of events 2 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
44.4%
4/9 • Number of events 6 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Investigations
Blood creatinine increased
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
General disorders
Chest pain
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
General disorders
Chills
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 3 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Psychiatric disorders
Confusional state
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
16.7%
2/12 • Number of events 2 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
25.0%
3/12 • Number of events 3 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
66.7%
6/9 • Number of events 6 • up to approximately 6 months
|
33.3%
1/3 • Number of events 1 • up to approximately 6 months
|
14.3%
2/14 • Number of events 2 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
14.3%
3/21 • Number of events 3 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 4 • up to approximately 6 months
|
33.3%
1/3 • Number of events 1 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
2/4 • Number of events 2 • up to approximately 6 months
|
18.2%
2/11 • Number of events 2 • up to approximately 6 months
|
50.0%
2/4 • Number of events 2 • up to approximately 6 months
|
14.3%
3/21 • Number of events 3 • up to approximately 6 months
|
25.0%
3/12 • Number of events 3 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
44.4%
4/9 • Number of events 4 • up to approximately 6 months
|
33.3%
1/3 • Number of events 1 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
25.0%
3/12 • Number of events 3 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
33.3%
2/6 • Number of events 3 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • Number of events 2 • up to approximately 6 months
|
18.2%
2/11 • Number of events 2 • up to approximately 6 months
|
25.0%
1/4 • Number of events 2 • up to approximately 6 months
|
19.0%
4/21 • Number of events 4 • up to approximately 6 months
|
25.0%
3/12 • Number of events 4 • up to approximately 6 months
|
50.0%
3/6 • Number of events 4 • up to approximately 6 months
|
66.7%
4/6 • Number of events 5 • up to approximately 6 months
|
42.9%
3/7 • Number of events 5 • up to approximately 6 months
|
33.3%
3/9 • Number of events 5 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
16.7%
2/12 • Number of events 2 • up to approximately 6 months
|
33.3%
2/6 • Number of events 2 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
33.3%
1/3 • Number of events 1 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Nervous system disorders
Dysgeusia
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
33.3%
3/9 • Number of events 3 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 2 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
9.5%
2/21 • Number of events 2 • up to approximately 6 months
|
33.3%
4/12 • Number of events 4 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
33.3%
2/6 • Number of events 3 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
14.3%
2/14 • Number of events 2 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
16.7%
1/6 • Number of events 2 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 2 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 2 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
33.3%
2/6 • Number of events 2 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
14.3%
2/14 • Number of events 2 • up to approximately 6 months
|
|
General disorders
Fatigue
|
100.0%
4/4 • Number of events 4 • up to approximately 6 months
|
36.4%
4/11 • Number of events 4 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
23.8%
5/21 • Number of events 6 • up to approximately 6 months
|
50.0%
6/12 • Number of events 6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
42.9%
3/7 • Number of events 3 • up to approximately 6 months
|
44.4%
4/9 • Number of events 4 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
14.3%
2/14 • Number of events 2 • up to approximately 6 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
16.7%
2/12 • Number of events 3 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
16.7%
2/12 • Number of events 2 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 3 • up to approximately 6 months
|
9.5%
2/21 • Number of events 2 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 2 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
22.2%
2/9 • Number of events 9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
21.4%
3/14 • Number of events 3 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/4 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
25.0%
1/4 • Number of events 1 • up to approximately 6 months
|
9.1%
1/11 • Number of events 1 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
14.3%
2/14 • Number of events 2 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • up to approximately 6 months
|
18.2%
2/11 • Number of events 2 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
14.3%
3/21 • Number of events 3 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
50.0%
3/6 • Number of events 4 • up to approximately 6 months
|
14.3%
1/7 • Number of events 2 • up to approximately 6 months
|
22.2%
2/9 • Number of events 3 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
14.3%
2/14 • Number of events 2 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
4.8%
1/21 • Number of events 1 • up to approximately 6 months
|
8.3%
1/12 • Number of events 1 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 3 • up to approximately 6 months
|
28.6%
2/7 • Number of events 2 • up to approximately 6 months
|
11.1%
1/9 • Number of events 2 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
9.5%
2/21 • Number of events 2 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
28.6%
2/7 • Number of events 2 • up to approximately 6 months
|
22.2%
2/9 • Number of events 2 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Investigations
Aspartate aminotransferase
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 2 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
33.3%
2/6 • Number of events 2 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
14.3%
2/14 • Number of events 2 • up to approximately 6 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 2 • up to approximately 6 months
|
33.3%
1/3 • Number of events 1 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
General disorders
Early satiety
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
14.3%
2/14 • Number of events 2 • up to approximately 6 months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
28.6%
2/7 • Number of events 2 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
33.3%
1/3 • Number of events 2 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Infections and infestations
Furuncle
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Musculoskeletal and connective tissue disorders
Gouty tophus
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 3 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 4 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
14.3%
2/14 • Number of events 2 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 3 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 2 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
33.3%
2/6 • Number of events 3 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
22.2%
2/9 • Number of events 2 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
General disorders
Injection site pain
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
General disorders
Injection site reaction
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
14.3%
2/14 • Number of events 2 • up to approximately 6 months
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
General disorders
Localised oedema
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 3 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
28.6%
4/14 • Number of events 4 • up to approximately 6 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 2 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
33.3%
2/6 • Number of events 2 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Vascular disorders
Pallor
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Nervous system disorders
Parosmia
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Rash pustular
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Eye disorders
Retinal tear
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
14.3%
1/7 • Number of events 1 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 2 • up to approximately 6 months
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
16.7%
1/6 • Number of events 1 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
14.3%
2/14 • Number of events 2 • up to approximately 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
0.00%
0/9 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
General disorders
Suprapubic pain
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Gastrointestinal disorders
Tongue blistering
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Nervous system disorders
Tongue paralysis
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Investigations
Troponin T increased
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
7.1%
1/14 • Number of events 1 • up to approximately 6 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
33.3%
2/6 • Number of events 2 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
22.2%
2/9 • Number of events 2 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/11 • up to approximately 6 months
|
0.00%
0/4 • up to approximately 6 months
|
0.00%
0/21 • up to approximately 6 months
|
0.00%
0/12 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/6 • up to approximately 6 months
|
0.00%
0/7 • up to approximately 6 months
|
11.1%
1/9 • Number of events 1 • up to approximately 6 months
|
0.00%
0/3 • up to approximately 6 months
|
0.00%
0/14 • up to approximately 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Study Agreement
- Publication restrictions are in place
Restriction type: OTHER