Trial Outcomes & Findings for PAK4 and NAMPT in Patients With Solid Malignancies or NHL (PANAMA) (NCT NCT02702492)
NCT ID: NCT02702492
Last Updated: 2024-11-25
Results Overview
The MTD was defined as the highest dose at which less than or equal to (\<=) 1 participant experienced a dose limiting toxicity (DLT) in Cycle 1. A DLT was defined as an adverse event (AE) or abnormal laboratory value occurring within the first 28 days of treatment of KPT-9274, excluding those clearly caused by underlying disease, disease progression, or external factors.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
From start of study drug administration up to 44 weeks
Results posted on
2024-11-25
Participant Flow
This study was conducted at 8 investigative sites in the United States and Canada from 08 Jun 2016 to 26 Jan 2021.
A total of 60 participants were enrolled and randomized to receive treatment in 2 phases, Dose Escalation (Part A \[23 participants\] and Part B \[27 participants\]; and Dose Expansion Phases (Part C \[10 participants\]). Study was terminated prematurely due to a lack of efficacy during primary analysis and therefore, efficacy, pharmacokinetic (PK) and pharmacodynamics (PDn) assessments were not determined.
Participant milestones
| Measure |
Part A: KPT-9274 10mg
Participants received 10 milligrams (mg) of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 20mg
Participants received 20mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 30mg
Participants received 30mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 40mg
Participants received 40mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 40mg BIW
Participants received KPT-9274 40mg of oral tablet biweekly (BIW) during each 28-day cycle.
|
Part B: KPT-9274 30mg + Niacin 500mg
Participants received KPT-9274 30mg of oral tablet along with a starting dose of 500mg niacin extended release (ER) orally three times a week every other day during each 28-day cycle
|
Part B: KPT-9274 40mg + Niacin 500mg
Participants received KPT-9274 40mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle
|
Part B: KPT-9274 60mg + Niacin 500mg
Participants received KPT-9274 60mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle
|
Part B: KPT-9274 80mg + Niacin 500mg
Participants received KPT-9274 80mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle
|
Part B: KPT-9274 100mg + Niacin 500mg
Participants received KPT-9274 100mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle
|
Part C: KPT-9274 20mg + Nivolumab 480mg
Participants received KPT-9274 20mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
Part C: KPT-9274 30mg + Nivolumab 480mg
Participants received KPT-9274 30mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
Part C: KPT-9274 40mg + Nivolumab 480mg
Participants received KPT-9274 40mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
5
|
7
|
5
|
3
|
4
|
12
|
7
|
1
|
1
|
5
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
5
|
7
|
5
|
3
|
4
|
12
|
7
|
1
|
1
|
5
|
4
|
Reasons for withdrawal
| Measure |
Part A: KPT-9274 10mg
Participants received 10 milligrams (mg) of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 20mg
Participants received 20mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 30mg
Participants received 30mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 40mg
Participants received 40mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 40mg BIW
Participants received KPT-9274 40mg of oral tablet biweekly (BIW) during each 28-day cycle.
|
Part B: KPT-9274 30mg + Niacin 500mg
Participants received KPT-9274 30mg of oral tablet along with a starting dose of 500mg niacin extended release (ER) orally three times a week every other day during each 28-day cycle
|
Part B: KPT-9274 40mg + Niacin 500mg
Participants received KPT-9274 40mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle
|
Part B: KPT-9274 60mg + Niacin 500mg
Participants received KPT-9274 60mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle
|
Part B: KPT-9274 80mg + Niacin 500mg
Participants received KPT-9274 80mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle
|
Part B: KPT-9274 100mg + Niacin 500mg
Participants received KPT-9274 100mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle
|
Part C: KPT-9274 20mg + Nivolumab 480mg
Participants received KPT-9274 20mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
Part C: KPT-9274 30mg + Nivolumab 480mg
Participants received KPT-9274 30mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
Part C: KPT-9274 40mg + Nivolumab 480mg
Participants received KPT-9274 40mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Disease progression
|
3
|
3
|
2
|
4
|
4
|
1
|
2
|
8
|
5
|
1
|
0
|
3
|
2
|
|
Overall Study
Clinical progression
|
0
|
0
|
2
|
1
|
0
|
2
|
1
|
4
|
0
|
0
|
1
|
2
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
2
|
1
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
1
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
PAK4 and NAMPT in Patients With Solid Malignancies or NHL (PANAMA)
Baseline characteristics by cohort
| Measure |
Part A: KPT-9274 10mg
n=3 Participants
Participants received 10mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 20mg
n=3 Participants
Participants received 20mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 30mg
n=5 Participants
Participants received 30mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 40mg
n=7 Participants
Participants received 40mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 40mg BIW
n=5 Participants
Participants received KPT-9274 40mg of oral tablet BIW during each 28-day cycle.
|
Part B: KPT-9274 30mg + Niacin 500mg
n=3 Participants
Participants received KPT-9274 30mg of oral tablet along with a starting dose of 500mg niacin extended release (ER) orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 40mg + Niacin 500mg
n=4 Participants
Participants received KPT-9274 40mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 60mg + Niacin 500mg
n=12 Participants
Participants received KPT-9274 60mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 80mg + Niacin 500mg
n=7 Participants
Participants received KPT-9274 80mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 100mg + Niacin 500mg
n=1 Participants
Participants received KPT-9274 100mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle
|
Part C: KPT-9274 20mg + Nivolumab 480mg
n=1 Participants
Participants received KPT-9274 20mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
Part C: KPT-9274 30mg + Nivolumab 480mg
n=5 Participants
Participants received KPT-9274 30mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
Part C: KPT-9274 40mg + Nivolumab 480mg
n=4 Participants
Participants received KPT-9274 40mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.3 Years
STANDARD_DEVIATION 16.62 • n=99 Participants
|
63.7 Years
STANDARD_DEVIATION 3.21 • n=107 Participants
|
56.6 Years
STANDARD_DEVIATION 6.77 • n=206 Participants
|
59.6 Years
STANDARD_DEVIATION 17.17 • n=7 Participants
|
68.8 Years
STANDARD_DEVIATION 4.66 • n=31 Participants
|
44.0 Years
STANDARD_DEVIATION 14.73 • n=30 Participants
|
65.0 Years
STANDARD_DEVIATION 4.55 • n=3 Participants
|
61.8 Years
STANDARD_DEVIATION 9.69 • n=6 Participants
|
55.0 Years
STANDARD_DEVIATION 15.00 • n=114 Participants
|
38.0 Years
STANDARD_DEVIATION NA
|
67.0 Years
STANDARD_DEVIATION NA • n=19 Participants
|
63.6 Years
STANDARD_DEVIATION 14.36 • n=4 Participants
|
62.0 Years
STANDARD_DEVIATION 10.20 • n=7 Participants
|
59.8 Years
STANDARD_DEVIATION 12.26 • n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=7 Participants
|
26 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
1 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=7 Participants
|
34 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=7 Participants
|
49 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
1 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
10 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
1 Participants
|
1 Participants
n=19 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=7 Participants
|
47 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to 44 weeksPopulation: Study was terminated prematurely due to a lack of efficacy. Therefore, the data were not determined due to insufficient number of participants with events.
The MTD was defined as the highest dose at which less than or equal to (\<=) 1 participant experienced a dose limiting toxicity (DLT) in Cycle 1. A DLT was defined as an adverse event (AE) or abnormal laboratory value occurring within the first 28 days of treatment of KPT-9274, excluding those clearly caused by underlying disease, disease progression, or external factors.
Outcome measures
| Measure |
Part A: KPT-9274 10mg
n=3 Participants
Participants received 10 milligrams (mg) of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 20mg
n=3 Participants
Participants received 20mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 30mg
n=5 Participants
Participants received 30mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 40mg
n=7 Participants
Participants received 40mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 40mg BIW
n=5 Participants
Participants received KPT-9274 40mg of oral tablet biweekly (BIW) during each 28-day cycle.
|
Part B: KPT-9274 30mg + Niacin 500mg
n=3 Participants
Participants received KPT-9274 30mg of oral tablet along with a starting dose of 500mg niacin extended release (ER) orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 40mg + Niacin 500mg
n=4 Participants
Participants received KPT-9274 40mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 60mg + Niacin 500mg
n=12 Participants
Participants received KPT-9274 60mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 80mg + Niacin 500mg
n=7 Participants
Participants received KPT-9274 80mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 100mg + Niacin 500mg
n=1 Participants
Participants received KPT-9274 100mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part C: KPT-9274 20mg + Nivolumab 480mg
n=1 Participants
Participants received KPT-9274 20mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
Part C: KPT-9274 30mg + Nivolumab 480mg
n=5 Participants
Participants received KPT-9274 30mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
Part C: KPT-9274 40mg + Nivolumab 480mg
n=4 Participants
Participants received KPT-9274 40mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) for KPT-9274
|
NA Participants
MTD was not determined based on insufficient number of participants with events.
|
NA Participants
MTD was not determined based on insufficient number of participants with events.
|
NA Participants
MTD was not determined based on insufficient number of participants with events.
|
NA Participants
MTD was not determined based on insufficient number of participants with events.
|
NA Participants
MTD was not determined based on insufficient number of participants with events.
|
NA Participants
MTD was not determined based on insufficient number of participants with events.
|
NA Participants
MTD was not determined based on insufficient number of participants with events.
|
NA Participants
MTD was not determined based on insufficient number of participants with events.
|
NA Participants
MTD was not determined based on insufficient number of participants with events.
|
NA Participants
MTD was not determined based on insufficient number of participants with events.
|
NA Participants
MTD was not determined based on insufficient number of participants with events.
|
NA Participants
MTD was not determined based on insufficient number of participants with events.
|
NA Participants
MTD was not determined based on insufficient number of participants with events.
|
PRIMARY outcome
Timeframe: At Cycle 1 only (28-day cycle)Population: The safety population consisted of all participants who had received at least 1 dose of the study treatment.
A DLT was defined as an AE or abnormal laboratory value occurring within the first 28 days of KPT-9274 treatment, excluding those clearly caused by underlying disease, disease progression, or extraneous causes, and meets any of the criteria for defining dose limiting toxicities.
Outcome measures
| Measure |
Part A: KPT-9274 10mg
n=3 Participants
Participants received 10 milligrams (mg) of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 20mg
n=3 Participants
Participants received 20mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 30mg
n=5 Participants
Participants received 30mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 40mg
n=7 Participants
Participants received 40mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 40mg BIW
n=5 Participants
Participants received KPT-9274 40mg of oral tablet biweekly (BIW) during each 28-day cycle.
|
Part B: KPT-9274 30mg + Niacin 500mg
n=3 Participants
Participants received KPT-9274 30mg of oral tablet along with a starting dose of 500mg niacin extended release (ER) orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 40mg + Niacin 500mg
n=4 Participants
Participants received KPT-9274 40mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 60mg + Niacin 500mg
n=12 Participants
Participants received KPT-9274 60mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 80mg + Niacin 500mg
n=7 Participants
Participants received KPT-9274 80mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 100mg + Niacin 500mg
n=1 Participants
Participants received KPT-9274 100mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part C: KPT-9274 20mg + Nivolumab 480mg
n=1 Participants
Participants received KPT-9274 20mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
Part C: KPT-9274 30mg + Nivolumab 480mg
n=5 Participants
Participants received KPT-9274 30mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
Part C: KPT-9274 40mg + Nivolumab 480mg
n=4 Participants
Participants received KPT-9274 40mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Dose Limiting Toxicities (DLT) Experienced by Participants
|
0 Number of DLTs
|
0 Number of DLTs
|
0 Number of DLTs
|
1 Number of DLTs
|
0 Number of DLTs
|
0 Number of DLTs
|
0 Number of DLTs
|
0 Number of DLTs
|
2 Number of DLTs
|
0 Number of DLTs
|
0 Number of DLTs
|
0 Number of DLTs
|
0 Number of DLTs
|
PRIMARY outcome
Timeframe: From start of study drug administration up to 49 weeksPopulation: The safety population consisted of all participants who had received at least 1 dose of the study treatment.
The AE severity was graded on a scale from 1 to 4 using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.03; any events not specifically listed in the scale were defined as: Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe or medically significant; Grade 4 is life-threatening. An SAE was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. The AE leading to treatment discontinuation in the study.
Outcome measures
| Measure |
Part A: KPT-9274 10mg
n=3 Participants
Participants received 10 milligrams (mg) of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 20mg
n=3 Participants
Participants received 20mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 30mg
n=5 Participants
Participants received 30mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 40mg
n=7 Participants
Participants received 40mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 40mg BIW
n=5 Participants
Participants received KPT-9274 40mg of oral tablet biweekly (BIW) during each 28-day cycle.
|
Part B: KPT-9274 30mg + Niacin 500mg
n=3 Participants
Participants received KPT-9274 30mg of oral tablet along with a starting dose of 500mg niacin extended release (ER) orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 40mg + Niacin 500mg
n=4 Participants
Participants received KPT-9274 40mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 60mg + Niacin 500mg
n=12 Participants
Participants received KPT-9274 60mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 80mg + Niacin 500mg
n=7 Participants
Participants received KPT-9274 80mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 100mg + Niacin 500mg
n=1 Participants
Participants received KPT-9274 100mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part C: KPT-9274 20mg + Nivolumab 480mg
n=1 Participants
Participants received KPT-9274 20mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
Part C: KPT-9274 30mg + Nivolumab 480mg
n=5 Participants
Participants received KPT-9274 30mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
Part C: KPT-9274 40mg + Nivolumab 480mg
n=4 Participants
Participants received KPT-9274 40mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Event (AE) of Severity Grade >= 3 or 4, Serious AEs, and AEs Leading to Treatment Discontinuation
Maximum Grade 3/4 AEs
|
1 Participants
|
2 Participants
|
5 Participants
|
7 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
10 Participants
|
7 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Adverse Event (AE) of Severity Grade >= 3 or 4, Serious AEs, and AEs Leading to Treatment Discontinuation
Maximum Grade 4 AEs
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Event (AE) of Severity Grade >= 3 or 4, Serious AEs, and AEs Leading to Treatment Discontinuation
Serious AEs
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Adverse Event (AE) of Severity Grade >= 3 or 4, Serious AEs, and AEs Leading to Treatment Discontinuation
AEs Leading to Study Treatment Discontinuation
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From date of randomization up to 44 weeksPopulation: Study was terminated prematurely due to a lack of efficacy during primary analysis stage. Data for this outcome measure was not collected or analyzed as per planned analysis.
The ORR was defined as percentage of participants who had a response of partial response (PR) or complete response (CR). The PR was achieved when a participant had at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The CR was achieved in a participant when all target lesions disappeared. Any pathological lymph nodes (whether target or non target) must have reduction in the short axis to \<10 millimeter (mm).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From date of the first study treatment up to 44 weeksPopulation: Study was terminated prematurely due to a lack of efficacy during primary analysis stage. Data for this outcome measure was not collected or analyzed as per planned analysis.
The DCR was defined as percentage of participants who have a response of CR, PR, and stable disease (SD) \>= 16 weeks, DCR = CR + PR+ SD. The PR was achieved when a participant had at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The CR was achieved in a participant when all target lesions disappeared. Any pathological lymph nodes (whether target or non-target) must have reduction in the short axis to \<10mm. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From the date of first study treatment until the first date of PD, or death due (up to 44 weeks)Population: Study was terminated prematurely due to a lack of efficacy during primary analysis stage. Data for this outcome measure was not collected or analyzed as per planned analysis.
The PFS was defined as the duration of time from date of the first study treatment until the first date that PD is objectively documented or death due to any cause. The PD is defined as at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded since the treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Appearance of one or more new lesions will also constitute PD.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From date of the first study treatment until death (up to 44 weeks)Population: Study was terminated prematurely due to a lack of efficacy during primary analysis stage. Data for this outcome measure was not collected or analyzed as per planned analysis.
The OS was defined as the duration of time from date of the first study treatment until death from any cause.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From date of the first study treatment until the first date of PD or death (up to 44 weeks)Population: Study was terminated prematurely due to a lack of efficacy during primary analysis stage. Data for this outcome measure was not collected or analyzed as per planned analysis.
The TTP was defined as the duration of time from date of the first study treatment until the first date that PD was objectively documented or death due to PD.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 44 weeksPopulation: Study was terminated prematurely due to a lack of efficacy during primary analysis stage. Data for this outcome measure was not collected or analyzed as per planned analysis.
The DOR was defined as the duration of time from the first meeting CR or PR measurement criteria (whichever occurs first) until the first date diseases progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 and 2: Pre-dose, 3, 6, 8, 24, and 48 hours post-dose (each cycle =28 days)Population: Study was terminated prematurely due to a lack of efficacy during primary analysis stage. Data for this outcome measure was not collected or analyzed as per planned analysis.
Cmax achieved by the KPT-9274 after the first dose administrations.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 and 2: Pre-dose, 3, 6, 8, 24, and 48 hours post-dose (each cycle =28 days)Population: Study was terminated prematurely due to a lack of efficacy during primary analysis stage. Data for this outcome measure was not collected or analyzed as per planned analysis.
Time taken by KPT-9274 to achieve maximum plasma concentration after the first dose administration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 and 2: Pre-dose, 3, 6, 8, 24, and 48 hours post-dose (each cycle =28 days)Population: Study was terminated prematurely due to a lack of efficacy during primary analysis stage. Data for this outcome measure was not collected or analyzed as per planned analysis.
The T1/2 was defied as the time it takes for the concentration of KPT-9274 in the plasma to be reduced by 50%.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 and 2: Pre-dose, 3, 6, 8, 24, and 48 hours post-dose (each cycle =28 days)Population: Study was terminated prematurely due to a lack of efficacy during primary analysis stage. Data for this outcome measure was not collected or analyzed as per planned analysis.
The Vd/F was defined as MRT\*CL/F, where MRT is the mean residence time (calculated as AUMC\[0-tau\]/AUC\[0-tau\], where AUMC\[0-tau\] is the area under the first moment curve determined as the area under the concentration\*time versus time curve).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 and 2: Pre-dose, 3, 6, 8, 24, and 48 hours post-dose (each cycle =28 days)Population: Study was terminated prematurely due to a lack of efficacy during primary analysis stage. Data for this outcome measure was not collected or analyzed as per planned analysis.
The CL/F was calculated as the KPT-9274 dose administered divided by the area-under-the-curve of KPT-9274 plasma concentration versus (vs) time.
Outcome measures
Outcome data not reported
Adverse Events
Part A: KPT-9274 10mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Part A: KPT-9274 20mg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Part A: KPT-9274 30mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 3 deaths
Part A: KPT-9274 40mg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 5 deaths
Part A: KPT-9274 40mg BIW
Serious events: 0 serious events
Other events: 5 other events
Deaths: 1 deaths
Part B: KPT-9274 30mg + Niacin 500mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Part B: KPT-9274 40mg + Niacin 500mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 3 deaths
Part B: KPT-9274 60mg + Niacin 500mg
Serious events: 6 serious events
Other events: 12 other events
Deaths: 6 deaths
Part B: KPT-9274 80mg + Niacin 500mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 4 deaths
Experimental: Part B: KPT-9274 100mg + Niacin 500mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Part C: KPT-9274 20mg + Nivolumab 480mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Part C: KPT-9274 30mg + Nivolumab 480mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 2 deaths
Part C: KPT-9274 40mg + Nivolumab 480mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Part A: KPT-9274 10mg
n=3 participants at risk
Participants received 10 milligrams (mg) of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 20mg
n=3 participants at risk
Participants received 20mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 30mg
n=5 participants at risk
Participants received 30mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 40mg
n=7 participants at risk
Participants received 40mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 40mg BIW
n=5 participants at risk
Participants received KPT-9274 40mg of oral tablet biweekly (BIW) during each 28-day cycle.
|
Part B: KPT-9274 30mg + Niacin 500mg
n=3 participants at risk
Participants received KPT-9274 30mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 40mg + Niacin 500mg
n=4 participants at risk
Participants received KPT-9274 40mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 60mg + Niacin 500mg
n=12 participants at risk
Participants received KPT-9274 60mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 80mg + Niacin 500mg
n=7 participants at risk
Participants received KPT-9274 80mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Experimental: Part B: KPT-9274 100mg + Niacin 500mg
n=1 participants at risk
Participants received KPT-9274 100mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part C: KPT-9274 20mg + Nivolumab 480mg
n=1 participants at risk
Participants received KPT-9274 20mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
Part C: KPT-9274 30mg + Nivolumab 480mg
n=5 participants at risk
Participants received KPT-9274 30mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
Part C: KPT-9274 40mg + Nivolumab 480mg
n=4 participants at risk
Participants received KPT-9274 40mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
40.0%
2/5 • From start of study drug administration up to 49 weeks
|
50.0%
2/4 • From start of study drug administration up to 49 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
General disorders
Death
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
16.7%
2/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
General disorders
Fatigue
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Investigations
Cardiac murmur
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Nervous system disorders
Intracranial mass
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
Other adverse events
| Measure |
Part A: KPT-9274 10mg
n=3 participants at risk
Participants received 10 milligrams (mg) of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 20mg
n=3 participants at risk
Participants received 20mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 30mg
n=5 participants at risk
Participants received 30mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 40mg
n=7 participants at risk
Participants received 40mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
|
Part A: KPT-9274 40mg BIW
n=5 participants at risk
Participants received KPT-9274 40mg of oral tablet biweekly (BIW) during each 28-day cycle.
|
Part B: KPT-9274 30mg + Niacin 500mg
n=3 participants at risk
Participants received KPT-9274 30mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 40mg + Niacin 500mg
n=4 participants at risk
Participants received KPT-9274 40mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 60mg + Niacin 500mg
n=12 participants at risk
Participants received KPT-9274 60mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part B: KPT-9274 80mg + Niacin 500mg
n=7 participants at risk
Participants received KPT-9274 80mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Experimental: Part B: KPT-9274 100mg + Niacin 500mg
n=1 participants at risk
Participants received KPT-9274 100mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
|
Part C: KPT-9274 20mg + Nivolumab 480mg
n=1 participants at risk
Participants received KPT-9274 20mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
Part C: KPT-9274 30mg + Nivolumab 480mg
n=5 participants at risk
Participants received KPT-9274 30mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
Part C: KPT-9274 40mg + Nivolumab 480mg
n=4 participants at risk
Participants received KPT-9274 40mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
28.6%
2/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
50.0%
2/4 • From start of study drug administration up to 49 weeks
|
16.7%
2/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
40.0%
2/5 • From start of study drug administration up to 49 weeks
|
57.1%
4/7 • From start of study drug administration up to 49 weeks
|
40.0%
2/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
25.0%
3/12 • From start of study drug administration up to 49 weeks
|
28.6%
2/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
50.0%
2/4 • From start of study drug administration up to 49 weeks
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Investigations
Glucose urine present
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
42.9%
3/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
66.7%
2/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
40.0%
2/5 • From start of study drug administration up to 49 weeks
|
100.0%
3/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
66.7%
2/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
41.7%
5/12 • From start of study drug administration up to 49 weeks
|
28.6%
2/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
16.7%
2/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Infections and infestations
Lyme disease
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
42.9%
3/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
25.0%
3/12 • From start of study drug administration up to 49 weeks
|
28.6%
2/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
40.0%
2/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
28.6%
2/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
60.0%
3/5 • From start of study drug administration up to 49 weeks
|
75.0%
3/4 • From start of study drug administration up to 49 weeks
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Investigations
Vitamin B12 decreased
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
28.6%
2/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
66.7%
2/3 • From start of study drug administration up to 49 weeks
|
100.0%
5/5 • From start of study drug administration up to 49 weeks
|
100.0%
7/7 • From start of study drug administration up to 49 weeks
|
100.0%
5/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
50.0%
2/4 • From start of study drug administration up to 49 weeks
|
66.7%
8/12 • From start of study drug administration up to 49 weeks
|
100.0%
7/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
100.0%
5/5 • From start of study drug administration up to 49 weeks
|
100.0%
4/4 • From start of study drug administration up to 49 weeks
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
16.7%
2/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
28.6%
2/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
16.7%
2/12 • From start of study drug administration up to 49 weeks
|
71.4%
5/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
57.1%
4/7 • From start of study drug administration up to 49 weeks
|
60.0%
3/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
75.0%
3/4 • From start of study drug administration up to 49 weeks
|
50.0%
6/12 • From start of study drug administration up to 49 weeks
|
71.4%
5/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
28.6%
2/7 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
75.0%
3/4 • From start of study drug administration up to 49 weeks
|
33.3%
4/12 • From start of study drug administration up to 49 weeks
|
42.9%
3/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
General disorders
Fatigue
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
40.0%
2/5 • From start of study drug administration up to 49 weeks
|
57.1%
4/7 • From start of study drug administration up to 49 weeks
|
40.0%
2/5 • From start of study drug administration up to 49 weeks
|
66.7%
2/3 • From start of study drug administration up to 49 weeks
|
50.0%
2/4 • From start of study drug administration up to 49 weeks
|
33.3%
4/12 • From start of study drug administration up to 49 weeks
|
71.4%
5/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
40.0%
2/5 • From start of study drug administration up to 49 weeks
|
50.0%
2/4 • From start of study drug administration up to 49 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
42.9%
3/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
50.0%
2/4 • From start of study drug administration up to 49 weeks
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
16.7%
2/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
28.6%
2/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Investigations
Weight decreased
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
25.0%
3/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
28.6%
2/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
42.9%
3/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
60.0%
3/5 • From start of study drug administration up to 49 weeks
|
71.4%
5/7 • From start of study drug administration up to 49 weeks
|
40.0%
2/5 • From start of study drug administration up to 49 weeks
|
66.7%
2/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
16.7%
2/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
60.0%
3/5 • From start of study drug administration up to 49 weeks
|
50.0%
2/4 • From start of study drug administration up to 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
40.0%
2/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
40.0%
2/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
16.7%
2/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
50.0%
2/4 • From start of study drug administration up to 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
General disorders
Chills
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
42.9%
3/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
25.0%
3/12 • From start of study drug administration up to 49 weeks
|
57.1%
4/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
50.0%
2/4 • From start of study drug administration up to 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
40.0%
2/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Eye disorders
Pupils unequal
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
General disorders
Pain
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Hepatobiliary disorders
Hepatic vein thrombosis
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Infections and infestations
Bronchitis
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
16.7%
2/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
50.0%
2/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
40.0%
2/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Investigations
Blood iron decreased
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Investigations
Lipase increased
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
66.7%
2/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Investigations
Reticulocyte count decreased
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
40.0%
2/5 • From start of study drug administration up to 49 weeks
|
28.6%
2/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
40.0%
2/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
40.0%
2/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
40.0%
2/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
16.7%
2/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
28.6%
2/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
66.7%
2/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
20.0%
1/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Reproductive system and breast disorders
Vaginal discharge
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
14.3%
1/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
33.3%
1/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
8.3%
1/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
Gastrointestinal disorders
Generalised oedema
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
100.0%
1/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/3 • From start of study drug administration up to 49 weeks
|
25.0%
1/4 • From start of study drug administration up to 49 weeks
|
0.00%
0/12 • From start of study drug administration up to 49 weeks
|
0.00%
0/7 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/1 • From start of study drug administration up to 49 weeks
|
0.00%
0/5 • From start of study drug administration up to 49 weeks
|
0.00%
0/4 • From start of study drug administration up to 49 weeks
|
Additional Information
Karyopharm Medical Information
Karyopharm Therapeutics Inc
Phone: (888) 209-9326
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place