Trial Outcomes & Findings for Determination of Safe Dose of Romiplostim (AMG 531) in Patients With Myelodysplastic Syndromes (MDS) (NCT NCT00303472)
NCT ID: NCT00303472
Last Updated: 2013-12-16
Results Overview
The number of participants experiencing one or more adverse events during the treatment phase or extension phase of Part A.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
Treatment period (4 weeks) plus treatment extension (1 year)
Results posted on
2013-12-16
Participant Flow
First Subject Enrolled: 15-Feb-2006 Last Subject Enrolled: 29-Feb-2008
The study had 3 parts: Part A (4 weeks), Part B (8 weeks), and a treatment extension phase (up to 1 year). Subjects could participate in either Part A or Part B, and then could choose to enter the treatment extension phase. Subjects participating in Part A were not eligible for participation in Part B.
Participant milestones
| Measure |
Part A: 300 µg Romiplostim
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part B: 750 µg Romiplostim SC QW
Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part B: 750 µg Romiplostim SC Q2W
Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part B: 750 µg Romiplostim IV Q2W
Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|---|---|---|
|
Treatment Period
STARTED
|
6
|
11
|
11
|
16
|
11
|
12
|
5
|
|
Treatment Period
COMPLETED
|
6
|
11
|
11
|
14
|
8
|
11
|
3
|
|
Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
2
|
3
|
1
|
2
|
|
Treatment Extension (Optional)
STARTED
|
6
|
11
|
11
|
13
|
5
|
5
|
1
|
|
Treatment Extension (Optional)
COMPLETED
|
1
|
5
|
2
|
5
|
1
|
4
|
1
|
|
Treatment Extension (Optional)
NOT COMPLETED
|
5
|
6
|
9
|
8
|
4
|
1
|
0
|
Reasons for withdrawal
| Measure |
Part A: 300 µg Romiplostim
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part B: 750 µg Romiplostim SC QW
Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part B: 750 µg Romiplostim SC Q2W
Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part B: 750 µg Romiplostim IV Q2W
Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|---|---|---|
|
Treatment Period
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Treatment Period
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Treatment Period
Other
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Treatment Period
Disease Progression (to AML)
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Extension (Optional)
Adverse Event
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Extension (Optional)
Death
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Extension (Optional)
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Extension (Optional)
Physician Decision
|
0
|
4
|
2
|
3
|
2
|
0
|
0
|
|
Treatment Extension (Optional)
Withdrawal by Subject
|
1
|
0
|
1
|
2
|
1
|
0
|
0
|
|
Treatment Extension (Optional)
Other
|
0
|
2
|
4
|
2
|
1
|
0
|
0
|
|
Treatment Extension (Optional)
Disease Progression (to AML)
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Determination of Safe Dose of Romiplostim (AMG 531) in Patients With Myelodysplastic Syndromes (MDS)
Baseline characteristics by cohort
| Measure |
Part A: 300 µg Romiplostim
n=6 Participants
Cohort 1 in Part A, participants received romiplostim 300 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
n=11 Participants
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
n=11 Participants
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
n=16 Participants
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part B: 750 µg Romiplostim SC QW
n=11 Participants
Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part B: 750 µg Romiplostim SC Q2W
n=12 Participants
Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part B: 750 µg Romiplostim IV Q2W
n=5 Participants
Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
77.5 Years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
68.2 Years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
70.9 Years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
68.9 Years
STANDARD_DEVIATION 13.8 • n=4 Participants
|
69.4 Years
STANDARD_DEVIATION 6.3 • n=21 Participants
|
72.1 Years
STANDARD_DEVIATION 9.9 • n=10 Participants
|
72.2 Years
STANDARD_DEVIATION 4.3 • n=115 Participants
|
70.7 Years
STANDARD_DEVIATION 10.6 • n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
18 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
54 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
63 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Aborigine
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Treatment period (4 weeks) plus treatment extension (1 year)Population: All participants who received at least one dose of study medication
The number of participants experiencing one or more adverse events during the treatment phase or extension phase of Part A.
Outcome measures
| Measure |
Part A: 300 µg Romiplostim
n=6 Participants
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
n=11 Participants
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
n=11 Participants
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
n=16 Participants
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|
|
Part A: Number of Participants With Adverse Events
|
6 Participants
|
11 Participants
|
11 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Treatment period (8 weeks) plus treatment extension (1 year)Population: All participants who received at least one dose of study medication
The number of participants experiencing one or more adverse events during the treatment phase or extension phase of Part B.
Outcome measures
| Measure |
Part A: 300 µg Romiplostim
n=11 Participants
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
n=12 Participants
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
n=5 Participants
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|
|
Part B: Number of Participants With Adverse Events
|
10 Participants
|
11 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Treatment Period (4 weeks)Population: Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase.
Participants with a complete or major response during the treatment phase. A complete platelet response was defined as a platelet count ≥ 100 x 10\^9/L during the treatment phase. A major platelet response was defined as an increase in absolute platelet count of ≥ 30 x 10\^9/L for patients starting with \> 20 x 10\^9/L platelets, or an increase from ≤ 20 x 10\^9/L to \> 20 x 10\^9/L and by at least 100%. Any participant receiving rescue medication was considered a non-responder. Platelet transfusions were considered rescue medication.
Outcome measures
| Measure |
Part A: 300 µg Romiplostim
n=6 Participants
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
n=11 Participants
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
n=11 Participants
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
n=16 Participants
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|
|
Part A: Number of Participants With a Complete or Major Platelet Response
|
3 Participants
|
5 Participants
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Treatment Period (8 weeks)Population: Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase.
Participants with a complete or major response during the treatment phase. A complete platelet response was defined as a platelet count ≥ 100 x 10\^9/L during the treatment phase. A major platelet response was defined as an increase in absolute platelet count of ≥ 30 x 10\^9/L for patients starting with \> 20 x 10\^9/L platelets, or an increase from ≤ 20 x 10\^9/L to \> 20 x 10\^9/L and by at least 100%. Any participant receiving rescue medication was considered a non-responder. Platelet transfusions were considered rescue medication.
Outcome measures
| Measure |
Part A: 300 µg Romiplostim
n=8 Participants
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
n=11 Participants
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
n=4 Participants
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|
|
Part B: Number of Participants With a Complete or Major Platelet Response
|
5 Participants
|
8 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Treatment period (4 weeks) and extension period (52 weeks).Population: Subset of Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase, who entered the treatment extension.
The number of participants with a platelet response according to the modified International Working Group (IWG) criteria. Response was defined as an absolute increase of ≥ 30 x 10\^9/L with Baseline platelet count \> 20 x 10\^9/L, or with a Baseline count ≤ 20 x 10\^9/L, increasing to above 20 x 10\^9/L and by at least 100% during the treatment or extension period and maintained for at least 8 consecutive weeks. Platelet transfusion was not considered a rescue medication but platelet counts ≤72 hours after platelet transfusion were excluded from the analysis.
Outcome measures
| Measure |
Part A: 300 µg Romiplostim
n=6 Participants
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
n=11 Participants
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
n=11 Participants
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
n=13 Participants
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|
|
Part A: Number of Participants With a Platelet Response Per IWG Criteria
|
3 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Treatment period (8 weeks) and extension period (52 weeks).Population: Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase
The number of participants with a platelet response according to the modified International Working Group (IWG) criteria. Response was defined as an absolute increase of ≥ 30 x 10\^9/L with Baseline platelet count \> 20 x 10\^9/L, or with a Baseline count ≤ 20 x 10\^9/L, increasing to above 20 x 10\^9/L and by at least 100% during the treatment or extension period and maintained for at least 8 consecutive weeks. Platelet transfusion was not considered a rescue medication but platelet counts ≤72 hours after platelet transfusion were excluded from the analysis.
Outcome measures
| Measure |
Part A: 300 µg Romiplostim
n=8 Participants
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
n=11 Participants
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
n=4 Participants
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|
|
Part B: Number of Participants With a Platelet Response Per IWG
|
2 Participants
|
4 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Treatment Period (8 weeks)Population: Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase.
Peak platelet count (10\^9/L) during the treatment period.
Outcome measures
| Measure |
Part A: 300 µg Romiplostim
n=8 Participants
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
n=11 Participants
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
n=4 Participants
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|
|
Part B: Peak Platelet Count
|
100.0 10^9/L
Interval 49.0 to 175.5
|
111.0 10^9/L
Interval 58.0 to 453.0
|
83.0 10^9/L
Interval 55.0 to 135.0
|
—
|
SECONDARY outcome
Timeframe: Treatment Period (8 weeks) and extension period (52 weeks).Population: Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase
Participants achieving first platelet response according to IWG criteria, by study week. Platelet response was defined as an absolute increase of ≥ 30 x 10\^9/L with Baseline platelet count \> 20 x 10\^9/L, or with a Baseline ≤ 20 x 10\^9/L increasing the platelet count to above 20 x 10\^9/L and by at least 100% for 8 consecutive weeks. Platelet counts obtained within 72 hours of platelet transfusion were not evaluable for platelet response.
Outcome measures
| Measure |
Part A: 300 µg Romiplostim
n=8 Participants
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
n=11 Participants
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
n=4 Participants
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|
|
Part B: Time to First Platelet Response
Week 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part B: Time to First Platelet Response
Week 5 or later
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part B: Time to First Platelet Response
Not Observed
|
6 Participants
|
7 Participants
|
3 Participants
|
—
|
|
Part B: Time to First Platelet Response
Week 1 Day 3
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part B: Time to First Platelet Response
Week 2
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Part B: Time to First Platelet Response
Week 3
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Treatment Period (8 weeks) and extension period (52 weeks)Population: Subset of Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase, who had a platelet response
Duration of platelet response per IWG criteria (absolute increase of ≥ 30 x 10\^9/L with Baseline platelet count \> 20 x 10\^9/L, or with a Baseline ≤ 20 x 10\^9/L increasing the platelet count to above 20 x 10\^9/L and by at least 100% for 8 consecutive weeks).
Outcome measures
| Measure |
Part A: 300 µg Romiplostim
n=2 Participants
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
n=4 Participants
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
n=1 Participants
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|
|
Part B: Duration of Platelet Response
|
19.5 Weeks
Interval 8.0 to 31.0
|
9.0 Weeks
Interval 8.0 to 10.5
|
9.0 Weeks
Interval 9.0 to 9.0
|
—
|
SECONDARY outcome
Timeframe: Week 1Population: Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim
Maximum observed serum concentration (Cmax) of romiplostim during Week 1
Outcome measures
| Measure |
Part A: 300 µg Romiplostim
n=4 Participants
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
n=5 Participants
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
n=4 Participants
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|
|
Part B: Week 1 Cmax
|
3660 pg/mL
Standard Deviation 3070
|
3190 pg/mL
Standard Deviation 2360
|
197000 pg/mL
Standard Deviation 112000
|
—
|
SECONDARY outcome
Timeframe: Week 1Population: Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim
Measured romiplostim concentration at the end of the week 1 dosing interval (Ctrough)
Outcome measures
| Measure |
Part A: 300 µg Romiplostim
n=11 Participants
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
n=9 Participants
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
n=5 Participants
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|
|
Part B: Week 1 Ctrough
|
171 pg/mL
Standard Deviation 212
|
35.2 pg/mL
Standard Deviation 31.5
|
96.5 pg/mL
Standard Deviation 127
|
—
|
SECONDARY outcome
Timeframe: Week 1Population: Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim
Area under the romiplostim concentration-time curve from time zero to the last time point with quantifiable concentration (AUC0-4) during Week 1
Outcome measures
| Measure |
Part A: 300 µg Romiplostim
n=4 Participants
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
n=5 Participants
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
n=4 Participants
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|
|
Part B: Week 1 AUC0-4
|
190000 hr*pg/mL
Standard Deviation 181000
|
182000 hr*pg/mL
Standard Deviation 111000
|
2030000 hr*pg/mL
Standard Deviation 838000
|
—
|
SECONDARY outcome
Timeframe: Week 7Population: Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim
Maximum observed serum concentration (Cmax) of romiplostim during Week 7.
Outcome measures
| Measure |
Part A: 300 µg Romiplostim
n=6 Participants
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
n=7 Participants
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|
|
Part B: Week 7 Cmax
|
785 pg/mL
Standard Deviation 906
|
357 pg/mL
Standard Deviation 361
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 7Population: Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim
Measured romiplostim concentration at the end of the Week 7 dosing interval (Ctrough)
Outcome measures
| Measure |
Part A: 300 µg Romiplostim
n=7 Participants
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
n=11 Participants
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|
|
Part B: Week 7 Ctrough
|
54.6 pg/mL
Standard Deviation 21.0
|
20.1 pg/mL
Standard Deviation 1.98
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 7Population: Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim
Area under the romiplostim concentration-time curve from time zero to the last time point with quantifiable concentration (AUC0-4) during Week 7.
Outcome measures
| Measure |
Part A: 300 µg Romiplostim
n=6 Participants
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
n=7 Participants
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|
|
Part B: Week 7 AUC0-4
|
57100 hr*pg/mL
Standard Deviation 64300
|
35500 hr*pg/mL
Standard Deviation 36400
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1Population: Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim
Time at which the maximum concentration of romiplostum was observed after subcutaneous administration during Week 1
Outcome measures
| Measure |
Part A: 300 µg Romiplostim
n=4 Participants
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
n=5 Participants
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|
|
Part B: Week 1 Tmax
|
24.0 Hours
Interval 24.0 to 24.0
|
24.0 Hours
Interval 24.0 to 24.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 7Population: Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim
Time at which the maximum concentration of romiplostum was observed after subcutaneous administration during Week 7
Outcome measures
| Measure |
Part A: 300 µg Romiplostim
n=6 Participants
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
n=7 Participants
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|
|
Part B: Week 7 Tmax
|
24.0 Hours
Interval 2.0 to 120.0
|
24.0 Hours
Interval 24.0 to 72.0
|
—
|
—
|
Adverse Events
Part A: 300 µg Romiplostim
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A: 700 µg Romiplostim
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Part A: 1000 µg Romiplostim
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Part A: 1500 µg Romiplostim
Serious events: 10 serious events
Other events: 15 other events
Deaths: 0 deaths
Part B: 750 µg Romiplostim SC QW
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Part B: 750 µg Romiplostim SC Q2W
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Part B: 750 µg Romiplostim IV Q2W
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: 300 µg Romiplostim
n=6 participants at risk
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
n=11 participants at risk
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
n=11 participants at risk
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
n=16 participants at risk
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part B: 750 µg Romiplostim SC QW
n=11 participants at risk
Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part B: 750 µg Romiplostim SC Q2W
n=12 participants at risk
Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part B: 750 µg Romiplostim IV Q2W
n=5 participants at risk
Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Lobar pneumonia
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.5%
2/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.5%
2/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.0%
1/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Coronary artery dissection
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.0%
1/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.0%
1/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chest pain
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
General physical health deterioration
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.0%
1/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Infection
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Blast cell count increased
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myelomonocytic leukaemia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Cerebral haemorrhage
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.0%
1/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Mental status changes
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Renal failure acute
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Other adverse events
| Measure |
Part A: 300 µg Romiplostim
n=6 participants at risk
Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 700 µg Romiplostim
n=11 participants at risk
Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1000 µg Romiplostim
n=11 participants at risk
Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part A: 1500 µg Romiplostim
n=16 participants at risk
Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part B: 750 µg Romiplostim SC QW
n=11 participants at risk
Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part B: 750 µg Romiplostim SC Q2W
n=12 participants at risk
Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
|
Part B: 750 µg Romiplostim IV Q2W
n=5 participants at risk
Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
|
|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Anaemia haemolytic autoimmune
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
16.7%
2/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Thrombocythaemia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Cataract
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
27.3%
3/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Eyelid irritation
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Keratitis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Lid lag
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Scleritis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
27.3%
3/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
3/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
31.2%
5/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Faecaloma
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
27.3%
3/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
16.7%
2/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Lip haemorrhage
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
31.2%
5/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Oral mucosal petechiae
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.5%
2/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Asthenia
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.0%
1/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Catheter related complication
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Catheter site haemorrhage
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Catheter site pain
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chest discomfort
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chest pain
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chills
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.5%
2/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Cyst
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Fatigue
|
66.7%
4/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
45.5%
5/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.8%
3/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
36.4%
4/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Gait disturbance
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Influenza like illness
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Infusion site haematoma
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Injection site bruising
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Injection site haematoma
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Injection site haemorrhage
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Injection site pain
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Oedema
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Oedema peripheral
|
50.0%
3/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.5%
2/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Pain
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Puncture site haemorrhage
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Temperature intolerance
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Cholecystitis
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Cellulitis
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Ear infection
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Eye infection
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Infection
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.5%
2/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.5%
2/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.0%
1/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pulmonary mycosis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.8%
3/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
2/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Contusion
|
33.3%
2/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.8%
3/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Excoriation
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Limb injury
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.0%
1/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.5%
2/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Cardiac murmur
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
General physical condition abnormal
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Heart rate irregular
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Weight decreased
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
27.3%
3/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Haemochromatosis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Oral intake reduced
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
27.3%
3/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
27.3%
3/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
27.3%
3/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
36.4%
4/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
27.3%
3/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.8%
3/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blast cell proliferation
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chloroma
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Cerebral atrophy
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Convulsion
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Depressed level of consciousness
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
27.3%
3/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.8%
3/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
36.4%
4/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.0%
1/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.0%
1/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Bereavement reaction
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Burnout syndrome
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Confusional state
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.5%
2/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Haematuria
|
33.3%
2/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Urinary incontinence
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Breast swelling
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
27.3%
3/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.5%
2/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.0%
1/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
27.3%
3/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal blistering
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.0%
1/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
33.3%
2/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Lentigo
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.2%
1/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.5%
2/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.3%
1/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
2/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
25.0%
4/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
16.7%
2/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.5%
2/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/6 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
1/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/16 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/11 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/12 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/5 • Every visit and up to 30 days after end of study (up to 64 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER