Trial Outcomes & Findings for A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies (NCT NCT00621244)
NCT ID: NCT00621244
Last Updated: 2021-01-05
Results Overview
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for consecutive dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
175 participants
Primary outcome timeframe
Cycle 1 (28-day treatment cycle)
Results posted on
2021-01-05
Participant Flow
Participant milestones
| Measure |
Arm 1, Group X
panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
|
Arm 1, Group Y
panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
|
Arm 2, Group X
panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
|
Arm 2, Group Y
panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
86
|
34
|
33
|
23
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
86
|
34
|
33
|
23
|
Reasons for withdrawal
| Measure |
Arm 1, Group X
panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
|
Arm 1, Group Y
panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
|
Arm 2, Group X
panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
|
Arm 2, Group Y
panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
3
|
3
|
3
|
|
Overall Study
Disease progression
|
44
|
20
|
20
|
15
|
|
Overall Study
Death
|
3
|
3
|
1
|
1
|
|
Overall Study
Adverse Event
|
27
|
7
|
9
|
2
|
|
Overall Study
Administrative problems
|
5
|
1
|
0
|
2
|
Baseline Characteristics
A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies
Baseline characteristics by cohort
| Measure |
Arm 1, Group X
n=86 Participants
panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
|
Arm 1, Group Y
n=34 Participants
panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
|
Arm 2, Group X
n=33 Participants
panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
|
Arm 2, Group Y
n=23 Participants
panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 12.11 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 17.27 • n=7 Participants
|
68.7 years
STANDARD_DEVIATION 8.75 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 17.41 • n=4 Participants
|
58.5 years
STANDARD_DEVIATION 16.97 • n=21 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
115 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (28-day treatment cycle)Population: MTD-determining set: Patients in the safety set who were in the dose escalation phase, and who received panobinostat for ≥ 9 full doses in arm 1 in cycle 1 and completed all needed safety evaluations; or who received panobinostat for ≥ 5 full doses in arm 2 in cycle 1 and completed all required safety evaluations; or who experienced DLT in cycle 1.
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for consecutive dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.
Outcome measures
| Measure |
Arm 1, Group X (20 mg)
n=7 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (30 mg)
n=6 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (40 mg)
n=8 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (60 mg) - MTD
n=12 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication.
|
Arm 1, Group X (80 mg)
n=6 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group Y (20 mg)
n=1 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (30 mg)
n=3 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (40 mg) - MTD
n=15 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (60 mg)
n=4 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants DLT in Arm 1 in Dose Escalation Phase
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (28-day treamtent cycle)Population: MTD-determining population: All patients from the safety population who were in the dose escalation phase of the study, and who received panobinostat for ≥ 9 full doses in arm 1 during cycle 1 and completed all required safety evaluations; or who received panobinostat.
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for intermittent dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.
Outcome measures
| Measure |
Arm 1, Group X (20 mg)
n=6 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (30 mg)
n=7 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (40 mg)
n=7 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (60 mg) - MTD
n=8 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication.
|
Arm 1, Group X (80 mg)
n=1 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group Y (20 mg)
n=6 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (30 mg)
n=13 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (40 mg) - MTD
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (60 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants DLT in Arm 2 in Dose Escalation Phase
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3.5 yearsPopulation: Full Analysis Set: defined according to the Intention to Treat (ITT) principle. This population set included all patients to whom study treatment had been assigned.
Response as per investigator assessment for patients include complete response, progressive disease/failure, stable disease.
Outcome measures
| Measure |
Arm 1, Group X (20 mg)
n=59 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (30 mg)
n=24 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (40 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (60 mg) - MTD
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication.
|
Arm 1, Group X (80 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group Y (20 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (30 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (40 mg) - MTD
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (60 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
|---|---|---|---|---|---|---|---|---|---|
|
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML)
Complete response (CR)
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML)
Partial remission (PR)
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML)
Stable disease (SD)
|
25 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML)
Progressive disease (PD)/failure
|
17 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML)
Not evaluable
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML)
Missing
|
11 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1.2 yearsPopulation: Full Analysis Set. Response as per investigator assessment for a subset of patients with AML accrued in the expansion phase (IA) include complete response, progressive disease/failure, stable disease.
Stage 2 did not open for enrollment.
Outcome measures
| Measure |
Arm 1, Group X (20 mg)
n=19 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (30 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (40 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (60 mg) - MTD
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication.
|
Arm 1, Group X (80 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group Y (20 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (30 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (40 mg) - MTD
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (60 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
|---|---|---|---|---|---|---|---|---|---|
|
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase
Complete response (CR)
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase
Progressive disease (PD)/failure
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase
Stable disease (SD)
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase
Not evaluable
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase
Missing
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3.5 yearsPopulation: Full Analysis Set
Response as per investigator assessment for patients include complete response, partial remission, stable disease, progressive disease (PD)/failure.
Outcome measures
| Measure |
Arm 1, Group X (20 mg)
n=22 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (30 mg)
n=10 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (40 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (60 mg) - MTD
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication.
|
Arm 1, Group X (80 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group Y (20 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (30 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (40 mg) - MTD
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (60 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
|---|---|---|---|---|---|---|---|---|---|
|
Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD)
Complete response (CR)
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD)
Partial remission (PR)
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD)
Stable disease (SD)
|
11 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD)
Progressive disease (PD)/failure
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD)
Missing
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3.5 yearsPopulation: Full Analysis Set
Response as per investigator assessment for patients include complete response, stable disease, progressive disease/failure, partial remission.
Outcome measures
| Measure |
Arm 1, Group X (20 mg)
n=9 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (30 mg)
n=2 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (40 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (60 mg) - MTD
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication.
|
Arm 1, Group X (80 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group Y (20 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (30 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (40 mg) - MTD
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (60 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
|---|---|---|---|---|---|---|---|---|---|
|
Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS)
Stable disease (SD)
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS)
Progressive disease (PD)/failure
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS)
Missing
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS)
Partial remission (PR)
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS)
Complete response (CR)
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Pharmacokinetic set: Pharmacokinetic population consisted of all patients who provided at least one postdose PK plasma sample.
Outcome measures
| Measure |
Arm 1, Group X (20 mg)
n=9 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (30 mg)
n=18 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (40 mg)
n=24 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (60 mg) - MTD
n=15 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication.
|
Arm 1, Group X (80 mg)
n=53 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group Y (20 mg)
n=18 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (30 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (40 mg) - MTD
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (60 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2
|
19.5 ng/mL
Standard Deviation 11.84
|
39.8 ng/mL
Standard Deviation 27.51
|
58 ng/mL
Standard Deviation 34.25
|
54 ng/mL
Standard Deviation 28.38
|
66.9 ng/mL
Standard Deviation 46.55
|
63.5 ng/mL
Standard Deviation 36.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Pharmacokinetic set
Outcome measures
| Measure |
Arm 1, Group X (20 mg)
n=9 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (30 mg)
n=18 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (40 mg)
n=24 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (60 mg) - MTD
n=15 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication.
|
Arm 1, Group X (80 mg)
n=53 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group Y (20 mg)
n=18 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (30 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (40 mg) - MTD
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (60 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
|---|---|---|---|---|---|---|---|---|---|
|
Half Life of Panobinostat After the First Dose in Arms 1 and 2
|
13.8 hour
Standard Deviation 6.65
|
18.2 hour
Standard Deviation 5.47
|
13.6 hour
Standard Deviation 3.26
|
19.7 hour
Standard Deviation 11.68
|
15.4 hour
Standard Deviation 4.14
|
14.6 hour
Standard Deviation 2.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15Population: Pharmacokinetic set
From day 15 by dose with schedule: MWF every week
Outcome measures
| Measure |
Arm 1, Group X (20 mg)
n=8 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (30 mg)
n=12 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (40 mg)
n=22 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (60 mg) - MTD
n=17 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication.
|
Arm 1, Group X (80 mg)
n=4 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group Y (20 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (30 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (40 mg) - MTD
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (60 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15
|
33.6 ng/mL
Standard Deviation 16.33
|
38.4 ng/mL
Standard Deviation 23.58
|
41.6 ng/mL
Standard Deviation 36.54
|
51.8 ng/mL
Standard Deviation 28.78
|
69.6 ng/mL
Standard Deviation 26.78
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15Population: Pharmacokinetic set
Outcome measures
| Measure |
Arm 1, Group X (20 mg)
n=8 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (30 mg)
n=12 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (40 mg)
n=22 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (60 mg) - MTD
n=17 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication.
|
Arm 1, Group X (80 mg)
n=4 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group Y (20 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (30 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (40 mg) - MTD
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (60 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
|---|---|---|---|---|---|---|---|---|---|
|
Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15
|
20.1 hour
Standard Deviation 7.06
|
19.7 hour
Standard Deviation 6.03
|
21.4 hour
Standard Deviation 8.87
|
17.9 hour
Standard Deviation 4.61
|
17.7 hour
Standard Deviation 8.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15/day 1Population: Pharmacokinetic set
MWF Every week schedule n = number of subjects with non-missing values.
Outcome measures
| Measure |
Arm 1, Group X (20 mg)
n=8 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (30 mg)
n=12 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (40 mg)
n=18 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (60 mg) - MTD
n=17 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication.
|
Arm 1, Group X (80 mg)
n=4 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group Y (20 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (30 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (40 mg) - MTD
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (60 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1
AUC
|
2.16 Ratio
Interval 1.68 to 2.77
|
1.07 Ratio
Interval 0.66 to 1.73
|
0.98 Ratio
Interval 0.78 to 1.22
|
1.17 Ratio
Interval 1.0 to 1.38
|
1.12 Ratio
Interval 0.58 to 2.15
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1
C (max) N=8,12,18,17,4
|
1.86 Ratio
Interval 1.41 to 2.45
|
1.02 Ratio
Interval 0.71 to 1.46
|
0.63 Ratio
Interval 0.45 to 0.89
|
0.74 Ratio
Interval 0.55 to 0.99
|
1.41 Ratio
Interval 0.89 to 2.21
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 5, 8, 10, 15Population: Full Analysis Set N=number of participants analyzed. total n=number of patients with a reading at the timepoint in the dose group.
Reporting the number of patients with a reading at the timepoint in the dose group.
Outcome measures
| Measure |
Arm 1, Group X (20 mg)
n=8 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (30 mg)
n=8 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (40 mg)
n=10 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (60 mg) - MTD
n=49 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication.
|
Arm 1, Group X (80 mg)
n=11 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group Y (20 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (30 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (40 mg) - MTD
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (60 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X
Day 1 (total=0, 1, 0, 0, 0)
|
NA Percentages of participants
No patients were analyzed for this arm.
|
100.0 Percentages of participants
|
NA Percentages of participants
No patients were analyzed for this arm.
|
NA Percentages of participants
No patients were analyzed for this arm.
|
NA Percentages of participants
No patients were analyzed for this arm.
|
—
|
—
|
—
|
—
|
|
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X
Day 10 (total=0, 0, 0, 0, 0, 1)
|
NA Percentages of participants
No patients were analyzed for this arm.
|
NA Percentages of participants
No patients were analyzed for this arm.
|
NA Percentages of participants
No patients were analyzed for this arm.
|
NA Percentages of participants
No patients were analyzed for this arm.
|
100.0 Percentages of participants
|
—
|
—
|
—
|
—
|
|
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X
Day 15 (total=3, 3, 4, 2, 2)
|
66.7 Percentages of participants
|
33.3 Percentages of participants
|
50.0 Percentages of participants
|
50.0 Percentages of participants
|
50.0 Percentages of participants
|
—
|
—
|
—
|
—
|
|
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X
Day 5 (total = 6, 4, 8, 17, 8)
|
100.0 Percentages of participants
|
75.0 Percentages of participants
|
87.5 Percentages of participants
|
82.4 Percentages of participants
|
37.5 Percentages of participants
|
—
|
—
|
—
|
—
|
|
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X
Day 8 (total = 5, 4, 8, 17, 7)
|
100.0 Percentages of participants
|
100.0 Percentages of participants
|
75.0 Percentages of participants
|
82.4 Percentages of participants
|
57.1 Percentages of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 5, 8, end of study (up to 3.5 years)Population: Full Analysis Set
Outcome measures
| Measure |
Arm 1, Group X (20 mg)
n=1 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (30 mg)
n=4 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (40 mg)
n=24 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (60 mg) - MTD
n=5 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication.
|
Arm 1, Group X (80 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group Y (20 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (30 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (40 mg) - MTD
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (60 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y
Day 5 (total= 1, 2, 15, 4)
|
100.0 Percentages of participants
|
100.0 Percentages of participants
|
66.7 Percentages of participants
|
75.0 Percentages of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y
Day 8 (total = 1, 3, 11, 4)
|
100.0 Percentages of participants
|
100.0 Percentages of participants
|
72.7 Percentages of participants
|
75.0 Percentages of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y
End of Study (total=1, 0, 0, 0)
|
0.0 Percentages of participants
|
NA Percentages of participants
No patients were analyzed for this arm.
|
NA Percentages of participants
No patients were analyzed for this arm.
|
NA Percentages of participants
No patients were analyzed for this arm.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 5, 8, 10, 12, 15, End of study, Unscheduled (up to 3.5 years)Population: Full Analysis Set
Outcome measures
| Measure |
Arm 1, Group X (20 mg)
n=6 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (30 mg)
n=9 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (40 mg)
n=9 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (60 mg) - MTD
n=9 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication.
|
Arm 1, Group X (80 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group Y (20 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (30 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (40 mg) - MTD
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (60 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X
Day 5 (total=4, 9, 6, 8)
|
50.0 Percentages of participants
|
88.9 Percentages of participants
|
83.3 Percentages of participants
|
100.0 Percentages of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X
Day 8 (total = 4, 7, 5, 7)
|
50.0 Percentages of participants
|
100.0 Percentages of participants
|
80.0 Percentages of participants
|
100.0 Percentages of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X
Day 10 (Total=3, 8, 5, 7)
|
33.3 Percentages of participants
|
37.5 Percentages of participants
|
80.0 Percentages of participants
|
100.0 Percentages of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X
Day 12 (Total=4, 6, 4, 8)
|
25.0 Percentages of participants
|
NA Percentages of participants
no patients with positive reading (greater than two fold increased when compared to baseline) at this time point in the dose group.
|
50.0 Percentages of participants
|
50.0 Percentages of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X
Day 15 (Total=4, 6, 2, 5)
|
75.0 Percentages of participants
|
50.0 Percentages of participants
|
100.0 Percentages of participants
|
60.0 Percentages of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X
End of Study (Total=1, 4, 2, 0)
|
100.0 Percentages of participants
|
75.0 Percentages of participants
|
50.0 Percentages of participants
|
0.0 Percentages of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X
Unscheduled (Total=2, 0, 0, 0)
|
50.0 Percentages of participants
|
NA Percentages of participants
No patients were analyzed for this arm.
|
NA Percentages of participants
No patients were analyzed for this arm.
|
NA Percentages of participants
No patients were analyzed for this arm.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 5, 8, 10, 12, 15, End of study (up to 3.5 years)Population: Full Analysis Set
Outcome measures
| Measure |
Arm 1, Group X (20 mg)
n=1 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (30 mg)
n=7 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (40 mg)
n=15 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (60 mg) - MTD
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication.
|
Arm 1, Group X (80 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group Y (20 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (30 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (40 mg) - MTD
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (60 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y
Day 5 (total=1, 4, 6)
|
100.0 Percentages of participants
|
100.0 Percentages of participants
|
100.0 Percentages of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y
Day 8 (total = 1, 4, 6)
|
100.0 Percentages of participants
|
100.0 Percentages of participants
|
83.3 Percentages of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y
Day 10 (total=1, 4, 5)
|
NA Percentages of participants
no patients with positive reading (greater than two fold increased when compared to baseline) at this time point in the dose group.
|
50.0 Percentages of participants
|
60.0 Percentages of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y
Day 12 (Total=0, 3, 5)
|
NA Percentages of participants
No patients were analyzed for this arm.
|
33.3 Percentages of participants
|
40.0 Percentages of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y
Day 15 (Total=1, 3, 5)
|
100.0 Percentages of participants
|
33.3 Percentages of participants
|
0 Percentages of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y
End of Study (Total=0, 2, 0)
|
NA Percentages of participants
No patients were analyzed for this arm.
|
50.0 Percentages of participants
|
NA Percentages of participants
No patients were analyzed for this arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Post dose to pre-dose (up to 3.5 years)Population: Full Analysis Set (with available samples for analysis)
All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days \[96 hours\]))
Outcome measures
| Measure |
Arm 1, Group X (20 mg)
n=8 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (30 mg)
n=4 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (40 mg)
n=7 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (60 mg) - MTD
n=21 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication.
|
Arm 1, Group X (80 mg)
n=8 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group Y (20 mg)
n=1 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (30 mg)
n=4 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (40 mg) - MTD
n=16 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (60 mg)
n=5 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
|---|---|---|---|---|---|---|---|---|---|
|
Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week)
|
56.6 Percent Change
Standard Deviation 97.26
|
22.5 Percent Change
Standard Deviation 45
|
63.2 Percent Change
Standard Deviation 87.21
|
591.4 Percent Change
Standard Deviation 2438.34
|
31 Percent Change
Standard Deviation 70.04
|
66.7 Percent Change
Standard Deviation NA
there was only 1 patient in the group, the standard deviation using the common Bessel correction cannot be derived.
|
150.0 Percent Change
Standard Deviation 125.59
|
196.3 Percent Change
Standard Deviation 193.25
|
1998.5 Percent Change
Standard Deviation 4250.04
|
SECONDARY outcome
Timeframe: Post dose to pre-dose (up to 3.5 years)Population: Full Analysis Set (with available samples for analysis)
All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days \[96 hours\]))
Outcome measures
| Measure |
Arm 1, Group X (20 mg)
n=3 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (30 mg)
n=8 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (40 mg)
n=7 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group X (60 mg) - MTD
n=6 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication.
|
Arm 1, Group X (80 mg)
n=1 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm 1, Group Y (20 mg)
n=4 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (30 mg)
n=10 Participants
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (40 mg) - MTD
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm 1, Group Y (60 mg)
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
|---|---|---|---|---|---|---|---|---|---|
|
Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week)
|
96.2 Percent Change
Standard Deviation 103.01
|
67.7 Percent Change
Standard Deviation 131.87
|
59.3 Percent Change
Standard Deviation 125.18
|
34.2 Percent Change
Standard Deviation 47.88
|
0.0 Percent Change
Standard Deviation NA
As the mean is 0, standard deviation is not applicable.
|
200.7 Percent Change
Standard Deviation 210.73
|
376.0 Percent Change
Standard Deviation 540.27
|
—
|
—
|
Adverse Events
Arm1, Group X (20 mg)
Serious events: 8 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm1, Group X (30 mg)
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm1, Group X (40 mg)
Serious events: 9 serious events
Other events: 10 other events
Deaths: 0 deaths
Arm1 GroupX 60 mg
Serious events: 34 serious events
Other events: 49 other events
Deaths: 0 deaths
Arm1 GroupX 80 mg
Serious events: 10 serious events
Other events: 11 other events
Deaths: 0 deaths
Arm1 GroupY 20 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm1 GroupY 30 mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm1 GroupY 40 mg
Serious events: 10 serious events
Other events: 24 other events
Deaths: 0 deaths
Arm1 GroupY 60 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm2 GroupX 30 mg
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm2 GroupX 45 mg
Serious events: 8 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm2 GroupX 60 mg
Serious events: 7 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm2 GroupX 80 mg
Serious events: 8 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm2 GroupY 30 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm2 GroupY 45 mg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm2 GroupY 60 mg
Serious events: 11 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm1, Group X (20 mg)
n=8 participants at risk
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm1, Group X (30 mg)
n=8 participants at risk
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm1, Group X (40 mg)
n=10 participants at risk
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm1 GroupX 60 mg
n=49 participants at risk
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm1 GroupX 80 mg
n=11 participants at risk
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm1 GroupY 20 mg
n=1 participants at risk
Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm1 GroupY 30 mg
n=4 participants at risk
Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm1 GroupY 40 mg
n=24 participants at risk
Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm1 GroupY 60 mg
n=5 participants at risk
Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm2 GroupX 30 mg
n=6 participants at risk
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm2 GroupX 45 mg
n=9 participants at risk
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm2 GroupX 60 mg
n=9 participants at risk
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm2 GroupX 80 mg
n=9 participants at risk
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm2 GroupY 30 mg
n=1 participants at risk
Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm2 GroupY 45 mg
n=7 participants at risk
Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm2 GroupY 60 mg
n=15 participants at risk
Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Blood creatinine increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Cardiac electrophysiologic study abnormal
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Lipase increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Transfusion-related circulatory overload
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
50.0%
2/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
4/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
40.0%
4/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
24.5%
12/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
36.4%
4/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
40.0%
2/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
2/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
3/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
3/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
3/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Femoral hernia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Catheter related complication
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Chest pain
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
13.3%
2/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Condition aggravated
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Disease progression
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Fatigue
|
37.5%
3/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
40.0%
4/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
27.3%
3/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
General physical health deterioration
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Generalised oedema
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Multi-organ failure
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Pyrexia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
2/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
3/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
3/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Alpha haemolytic streptococcal infection
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Arthritis viral
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Catheter sepsis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Penile abscess
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Pharyngitis
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.2%
4/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Sepsis
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.2%
4/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Septic shock
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Serratia infection
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Staphylococcal bacteraemia
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Liver function test abnormal
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Troponin I increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Troponin increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Fluid imbalance
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Myofascitis
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemic infiltration brain
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukostasis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour lysis syndrome
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Convulsion
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Syncope
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse alveolar damage
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
13.3%
2/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Surgical and medical procedures
Catheter removal
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
Other adverse events
| Measure |
Arm1, Group X (20 mg)
n=8 participants at risk
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm1, Group X (30 mg)
n=8 participants at risk
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm1, Group X (40 mg)
n=10 participants at risk
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm1 GroupX 60 mg
n=49 participants at risk
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm1 GroupX 80 mg
n=11 participants at risk
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm1 GroupY 20 mg
n=1 participants at risk
Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm1 GroupY 30 mg
n=4 participants at risk
Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm1 GroupY 40 mg
n=24 participants at risk
Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm1 GroupY 60 mg
n=5 participants at risk
Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm2 GroupX 30 mg
n=6 participants at risk
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm2 GroupX 45 mg
n=9 participants at risk
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm2 GroupX 60 mg
n=9 participants at risk
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm2 GroupX 80 mg
n=9 participants at risk
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
|
Arm2 GroupY 30 mg
n=1 participants at risk
Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm2 GroupY 45 mg
n=7 participants at risk
Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
Arm2 GroupY 60 mg
n=15 participants at risk
Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Weight increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
2/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.2%
4/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Anorexia
|
62.5%
5/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
50.0%
4/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
60.0%
6/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
65.3%
32/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
54.5%
6/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
41.7%
10/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
2/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
3/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
3/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
57.1%
4/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
53.3%
8/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Activated partial thromboplastin time shortened
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Anaemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Anti-erythrocyte antibody positive
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Antithrombin III decreased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Aspiration biopsy
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Biopsy skin
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Blood albumin decreased
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Blood alkaline phosphatase increased
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Blood calcium decreased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.4%
10/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
36.4%
4/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
26.7%
4/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Blood glucose increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Blood sodium increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
3/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Blood triglycerides increased
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Blood urea increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Blood uric acid increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
C-reactive protein increased
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
7/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
26.7%
4/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Clostridium difficile toxin test positive
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Computerised tomogram abnormal
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Electrocardiogram QRS complex prolonged
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Electrocardiogram QT prolonged
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
36.4%
4/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Electrocardiogram ST segment abnormal
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Electrocardiogram ST-T change
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Electrocardiogram repolarisation abnormality
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Fungus stool identified
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Hypophosphataemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
International normalised ratio increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Liver function test abnormal
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Oxygen saturation increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Prothrombin time shortened
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Red blood cells urine positive
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Transaminases increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Troponin increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Urine output decreased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Investigations
Weight decreased
|
37.5%
3/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
37.5%
3/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
30.0%
3/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
34.7%
17/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
36.4%
4/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
45.8%
11/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
2/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
42.9%
3/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
3/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.4%
9/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
3/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
3/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Gout
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.2%
4/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
3/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.2%
5/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
26.7%
4/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Podagra
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
13.3%
2/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
50.0%
4/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
2/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
34.7%
17/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
54.5%
6/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
44.4%
4/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
26.7%
4/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
4/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
62.5%
5/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
42.9%
21/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
63.6%
7/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
8/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
60.0%
3/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
2/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
3/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
28.6%
2/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
26.7%
4/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.2%
6/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
40.0%
2/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
2/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
7/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.4%
9/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
40.0%
2/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
3/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
13.3%
2/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Vitamin B6 deficiency
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
2/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
27.3%
3/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
100.0%
1/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
100.0%
1/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
26.7%
4/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.4%
9/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
27.3%
3/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
100.0%
1/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.8%
5/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
3/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
13.3%
2/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
5/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
50.0%
2/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
100.0%
1/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
50.0%
4/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
2/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
36.7%
18/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
45.5%
5/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.8%
5/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
28.6%
2/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
5/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.2%
4/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Facial palsy
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Periostitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
100.0%
1/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
30.0%
3/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.4%
10/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
4/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
40.0%
6/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour lysis syndrome
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Ageusia
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Aphasia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Balance disorder
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Coma
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Convulsion
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
30.0%
3/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
7/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
3/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
2/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Hypokinesia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Lethargy
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.2%
4/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
3/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
13.3%
2/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Meningeal disorder
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Peripheral paralysis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Syncope
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Nervous system disorders
Tremor
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Psychiatric disorders
Agitation
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.2%
5/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
13.3%
2/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.2%
4/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Psychiatric disorders
Depression
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
2/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.4%
11/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
28.6%
2/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
2/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Psychiatric disorders
Sleep disorder
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Dysuria
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Ketonuria
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Renal failure acute
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.2%
4/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.2%
4/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Reproductive system and breast disorders
Breast swelling
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
50.0%
5/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
24.5%
12/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
29.2%
7/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
40.0%
2/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
28.6%
2/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
5/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
4/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
37.5%
3/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
40.0%
4/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.4%
11/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
54.5%
6/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
4/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
44.4%
4/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
3/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
28.6%
2/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
26.7%
4/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exacerbated
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
37.5%
3/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
24.5%
12/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
6/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
2/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
100.0%
1/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
3/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Hypocapnia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
2/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.2%
4/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
3/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
27.3%
3/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
13.3%
2/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
13.3%
2/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory gas exchange disorder
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
13.3%
2/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.2%
4/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.2%
4/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
3/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
50.0%
4/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.3%
8/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
36.4%
4/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
13.3%
2/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
2/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.2%
6/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
13.3%
2/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
100.0%
1/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Vascular disorders
Flushing
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Vascular disorders
Haematoma
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
2/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.2%
6/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
2/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Vascular disorders
Hypotension
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.3%
8/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
3/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Vascular disorders
Orthostatic hypertension
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Vascular disorders
Phlebitis
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Vascular disorders
Venoocclusive disease
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Anaemia
|
37.5%
3/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
37.5%
3/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
44.9%
22/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
37.5%
9/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
3/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
44.4%
4/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
28.6%
2/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
46.7%
7/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Coagulopathy
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
4/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Hypoprothrombinaemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.2%
6/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
2/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
36.7%
18/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
100.0%
1/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
50.0%
2/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
8/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
40.0%
2/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
44.4%
4/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
66.7%
6/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
28.6%
2/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
40.0%
6/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
37.5%
3/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
40.0%
4/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
53.1%
26/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
27.3%
3/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
100.0%
1/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
100.0%
4/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
91.7%
22/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
100.0%
5/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
3/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
3/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
66.7%
6/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
100.0%
1/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
57.1%
4/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
73.3%
11/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Atrial fibrillation
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Bradycardia
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Dilatation ventricular
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.2%
6/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
27.3%
3/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
13.3%
2/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Cardiac disorders
Ventricular extrasystoles
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Congenital, familial and genetic disorders
Antithrombin III deficiency
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Ear and labyrinth disorders
Deafness
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
2/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.2%
5/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Endocrine disorders
Goitre
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Eye disorders
Conjunctivitis
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Eye disorders
Diplopia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Eye disorders
Eye irritation
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Eye disorders
Hyphaema
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Eye disorders
Keratoconjunctivitis sicca
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Eye disorders
Ocular icterus
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Eye disorders
Pupillary disorder
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Eye disorders
Visual Impairment
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Eye disorders
Visual disturbance
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
30.0%
3/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
32.7%
16/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
29.2%
7/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
3/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
3/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
2/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.2%
5/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Anal discomfort
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Anal haemorrhage
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Caecitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
26.5%
13/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
27.3%
3/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
29.2%
7/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
2/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
44.4%
4/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
5/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
62.5%
5/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
62.5%
5/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
50.0%
5/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
83.7%
41/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
90.9%
10/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
75.0%
3/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
62.5%
15/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
50.0%
3/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
44.4%
4/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
66.7%
6/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
55.6%
5/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
100.0%
1/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
71.4%
5/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
66.7%
10/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
2/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.2%
6/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
6/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
3/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
7/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
28.6%
2/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Gingival bleeding
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Gingival disorder
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Haemorrhoids
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Lip haemorrhage
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
2/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Mouth ulceration
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.2%
5/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
50.0%
3/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
13.3%
2/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Nausea
|
62.5%
5/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
62.5%
5/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
90.0%
9/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
63.3%
31/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
72.7%
8/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
66.7%
16/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
60.0%
3/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
66.7%
4/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
3/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
77.8%
7/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
77.8%
7/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
100.0%
1/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
85.7%
6/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
80.0%
12/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Oral mucosal petechiae
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.2%
6/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Pancreatic calcification
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Saliva altered
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Stomatitis haemorrhagic
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
4/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
80.0%
8/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
46.9%
23/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
54.5%
6/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
37.5%
9/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
2/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
55.6%
5/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
44.4%
4/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
100.0%
1/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
71.4%
5/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
46.7%
7/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Catheter related complication
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
13.3%
2/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Catheter site oedema
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Catheter site pain
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Catheter site related reaction
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Chest pain
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.2%
5/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Chills
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
40.0%
4/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
30.6%
15/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
3/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Chronic fatigue syndrome
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Cyst
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Face oedema
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Fatigue
|
37.5%
3/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
62.5%
5/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
70.0%
7/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
73.5%
36/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
72.7%
8/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
100.0%
1/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
79.2%
19/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
60.0%
3/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
50.0%
3/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
66.7%
6/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
44.4%
4/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
55.6%
5/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
85.7%
6/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
80.0%
12/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Feeling cold
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Gait disturbance
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
General physical health deterioration
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Hyperthermia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Hypothermia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Inflammation
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Influenza like illness
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Local swelling
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Malaise
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
2/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Mass
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Mucosal haemorrhage
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Mucosal inflammation
|
37.5%
3/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
37.5%
3/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
2/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
18.2%
2/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Non-cardiac chest pain
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
3/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
100.0%
1/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Oedema mucosal
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Oedema peripheral
|
37.5%
3/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
40.0%
4/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
32.7%
16/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
36.4%
4/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
50.0%
2/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
6/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
42.9%
3/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
3/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Pain
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Pitting oedema
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Pyrexia
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
50.0%
4/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
2/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
32.7%
16/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
27.3%
3/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.8%
5/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
40.0%
2/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
33.3%
2/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
44.4%
4/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
44.4%
4/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
42.9%
3/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
26.7%
4/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Sensation of blood flow
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
General disorders
Thirst decreased
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.2%
4/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Immune system disorders
Immunodeficiency
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Anal abscess
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Anal candidiasis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Aspergillosis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.2%
4/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Candida pneumonia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Candidiasis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
13.3%
2/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Catheter sepsis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Condyloma acuminatum
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Enterococcal infection
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Folliculitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Gastroenteritis
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Infection
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
50.0%
2/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Micrococcal sepsis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Oral candidiasis
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.2%
4/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Otitis externa
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Paronychia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Rash pustular
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Respiratory tract infection
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
100.0%
1/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
50.0%
2/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.8%
5/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
16.7%
1/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
3/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
100.0%
1/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Sepsis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Staphylococcal infection
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
20.0%
1/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Tracheitis
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Urinary tract infection
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
22.2%
2/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Viral infection
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
2.0%
1/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
14.3%
1/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
8.3%
2/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Haemothorax
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Open wound
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Post procedural oedema
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
10.0%
1/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.1%
2/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
9.1%
1/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
25.0%
1/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
4.2%
1/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Scratch
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
11.1%
1/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
12.5%
1/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.7%
1/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
25.0%
2/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/8 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/10 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
6.1%
3/49 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/11 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/4 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/24 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/5 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/6 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/9 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/1 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/7 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
0.00%
0/15 • AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigators from publishing. Any publications from a single-site are postponed until the publication of the polled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER