Trial Outcomes & Findings for Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients (NCT NCT04097821)
NCT ID: NCT04097821
Last Updated: 2025-08-07
Results Overview
Incidence and severity of dose limiting toxicities within the first 2 cycles (6 or 8 weeks) in Part 1 of the study. DLTs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) criteria Version 5.0. Grade 0 was assigned for all non-missing values not graded as 1 or higher. Higher grade indicated more severity. Grade 5 was not used.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Baseline to the end of Cycle 2 (6 or 8 weeks)
Results posted on
2025-08-07
Participant Flow
All inclusion and exclusion criteria were checked at screening.
Participant milestones
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
Part 2: Ruxolitinib
Existing stable dose of ruxolitinib as control for Part 2
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
10
|
6
|
9
|
6
|
2
|
4
|
1
|
|
Overall Study
COMPLETED
|
6
|
8
|
2
|
6
|
4
|
0
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
4
|
3
|
2
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
Part 2: Ruxolitinib
Existing stable dose of ruxolitinib as control for Part 2
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Subject Decision
|
0
|
0
|
0
|
1
|
2
|
2
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
3
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
New Therapy For Study Indication
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients
Baseline characteristics by cohort
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=7 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
n=10 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
n=6 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
n=9 Participants
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
n=6 Participants
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
n=2 Participants
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
n=4 Participants
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
Part 2: Ruxolitinib
Existing stable dose of ruxolitinib as control for Part 2
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
70.6 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
62.3 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
74.3 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
67.3 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
65.0 years
STANDARD_DEVIATION 8.1 • n=21 Participants
|
62.5 years
STANDARD_DEVIATION 12.0 • n=8 Participants
|
70.8 years
STANDARD_DEVIATION 7.3 • n=8 Participants
|
—
|
67.4 years
STANDARD_DEVIATION 9.2 • n=42 Participants
|
|
Age, Customized
<65
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
—
|
17 Participants
n=42 Participants
|
|
Age, Customized
>=65
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
—
|
27 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
—
|
12 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
—
|
32 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
—
|
42 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
—
|
2 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline to the end of Cycle 2 (6 or 8 weeks)Population: The dose-determining set included all subjects from the safety run-in and dose escalation part (Part 1) of the study who met the minimum exposure criterion and had sufficient safety evaluations or experienced a DLT between C1D1 and C3D1. Number analyzed is the number of participants with available data.
Incidence and severity of dose limiting toxicities within the first 2 cycles (6 or 8 weeks) in Part 1 of the study. DLTs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) criteria Version 5.0. Grade 0 was assigned for all non-missing values not graded as 1 or higher. Higher grade indicated more severity. Grade 5 was not used.
Outcome measures
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=6 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
n=7 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
n=5 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
n=9 Participants
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
n=5 Participants
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
n=2 Participants
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
|---|---|---|---|---|---|---|---|
|
Incidence and Severity of Dose Limiting Toxicities Within the First 2 Cycles in Part 1
Grade 3
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
—
|
|
Incidence and Severity of Dose Limiting Toxicities Within the First 2 Cycles in Part 1
Grade 4
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline to the end of Cycle 6 or 8 (24 weeks)Population: Enrollment was permanently halted; therefore, data were not collected for this outcome measure.
Composite of anemia improvement (hemoglobin level) and no spleen volume progression and no symptom worsening in Part 2 and Part 3 of the study. For a subject to be considered a responder, all three components of the composite had to be fulfilled.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24, Week 48Population: The full analysis set included all subjects who received any study drug.
Outcome measures
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=7 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
n=10 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
n=6 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
n=9 Participants
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
n=6 Participants
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
n=2 Participants
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
n=4 Participants
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Achieving an Improvement in Hemoglobin Level of ≥ 1.5 g/dL From Baseline in Part 1
Week 24
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects Achieving an Improvement in Hemoglobin Level of ≥ 1.5 g/dL From Baseline in Part 1
Week 48
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24, Week 48Population: The full analysis set included all subjects who received any study drug.
Outcome measures
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=7 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
n=10 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
n=6 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
n=9 Participants
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
n=6 Participants
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
n=2 Participants
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
n=4 Participants
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Achieving an Improvement in Hemoglobin Level of at Least >= 2.0 g/dL From Baseline in Part 1
Week 24
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects Achieving an Improvement in Hemoglobin Level of at Least >= 2.0 g/dL From Baseline in Part 1
Week 48
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48Population: The full analysis set included all subjects who received any study drug. Number analyzed is the number of participants with available data.
Change in spleen length measured in centimeters by manual palpation.
Outcome measures
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=6 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
n=8 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
n=4 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
n=4 Participants
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
n=4 Participants
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
|---|---|---|---|---|---|---|---|
|
Change in Spleen Length From Baseline in Part 1
Week 24 n=6,8,4,4,4,0,0
|
-3.3 centimeters
Standard Deviation 2.6
|
-5.5 centimeters
Standard Deviation 3.9
|
-6.3 centimeters
Standard Deviation 4.6
|
-1.8 centimeters
Standard Deviation 3.9
|
-1.5 centimeters
Standard Deviation 1.9
|
—
|
—
|
|
Change in Spleen Length From Baseline in Part 1
Week 48 n=2,1,2,1,1,0,0
|
-5.0 centimeters
Standard Deviation 0.0
|
-9.0 centimeters
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
-6.0 centimeters
Standard Deviation 7.1
|
-8.0 centimeters
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
-5.0 centimeters
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24, Week 48Population: The full analysis set included all subjects who received any study drug.
Change in spleen volume measured by magnetic resonance imaging (MRI) or computed tomography (CT) from baseline.
Outcome measures
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=7 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
n=10 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
n=6 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
n=9 Participants
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
n=6 Participants
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
n=2 Participants
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
n=4 Participants
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With >=35% Reduction in Spleen Volume From Baseline in Part 1
Week 24
|
14.3 percentage of participants
|
60.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects With >=35% Reduction in Spleen Volume From Baseline in Part 1
Week 48
|
14.3 percentage of participants
|
10.0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24, Week 48Population: The full analysis set included all subjects who received any study drug.
Change in spleen volume measured by magnetic resonance imaging (MRI) or computed tomography (CT) from baseline.
Outcome measures
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=7 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
n=10 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
n=6 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
n=9 Participants
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
n=6 Participants
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
n=2 Participants
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
n=4 Participants
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With >=25% Reduction in Spleen Volume From Baseline in Part 1
Week 48
|
28.6 percentage of participants
|
10.0 percentage of participants
|
16.7 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects With >=25% Reduction in Spleen Volume From Baseline in Part 1
Week 24
|
28.6 percentage of participants
|
60.0 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12, Week 24, Week 48Population: The full analysis set included all subjects who received any study drug.
The MFSAF v4.0 questionnaire focuses on the 7 core symptoms of MF: fatigue, night sweats, pruritus, abdominal discomfort, pain under the ribs on the left side, early satiety and bone pain. Subjects record symptom severity at it worst for each of the 7 symptoms on an 11-point numeric rating scale, from 0 (absent) to 10 (worst imaginable). The Total Symptom Score (TSS) is the sum of all the scores for all 7 symptoms.
Outcome measures
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=7 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
n=10 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
n=6 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
n=9 Participants
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
n=6 Participants
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
n=2 Participants
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
n=4 Participants
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
|---|---|---|---|---|---|---|---|
|
Percentage of Subjects in Part 1 With >=50% Reduction From Baseline in Myelofibrosis Symptom Assessment Form, Version 4.0 (MFSAF v4.0)
Week 12
|
42.9 percentage of participants
|
30.0 percentage of participants
|
16.7 percentage of participants
|
11.1 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects in Part 1 With >=50% Reduction From Baseline in Myelofibrosis Symptom Assessment Form, Version 4.0 (MFSAF v4.0)
Week 24
|
14.3 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
11.1 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects in Part 1 With >=50% Reduction From Baseline in Myelofibrosis Symptom Assessment Form, Version 4.0 (MFSAF v4.0)
Week 48
|
14.3 percentage of participants
|
10.0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1 and 5 of Cycles 1 and 2 for siremadlin and Cycles 1 and 3 for crizanlizumab, sabatolimab, and NIS793; Days 1 and 15 of Cycle 1 for rineterkibPopulation: The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Outcome measures
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=6 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
n=9 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
n=5 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
n=9 Participants
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
n=5 Participants
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
n=2 Participants
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
n=4 Participants
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Cycle 1 Day 1 n=6,9,5,9,5,2,4
|
1520 ng*hr/mL
Standard Deviation 619
|
2560 ng*hr/mL
Standard Deviation 1530
|
3780 ng*hr/mL
Standard Deviation 1840
|
6000 ng*hr/mL
Standard Deviation 5120
|
14100000 ng*hr/mL
Standard Deviation 4990000
|
34900 ng*hr/mL
Standard Deviation 7860
|
103000000 ng*hr/mL
Standard Deviation 18700000
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Cycle 1 Day 5 n=6,7,5,0,0,0,0
|
2230 ng*hr/mL
Standard Deviation 1110
|
3340 ng*hr/mL
Standard Deviation 2120
|
4390 ng*hr/mL
Standard Deviation 2270
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Cycle 2 Day 1 n=5,6,3,0,0,0,0
|
1720 ng*hr/mL
Standard Deviation 1020
|
2400 ng*hr/mL
Standard Deviation 1150
|
2870 ng*hr/mL
Standard Deviation 326
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Cycle 2 Day 5 n=3,5,3,0,0,0,0
|
1590 ng*hr/mL
Standard Deviation 577
|
2860 ng*hr/mL
Standard Deviation 1680
|
3030 ng*hr/mL
Standard Deviation 786
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Cycle 1 Day 15 n=0,0,0,9,0,0,0
|
—
|
—
|
—
|
15800 ng*hr/mL
Standard Deviation 11000
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Cycle 3 Day 1 n=0,0,0,0,5,2,3
|
—
|
—
|
—
|
—
|
20900000 ng*hr/mL
Standard Deviation 13000000
|
43500 ng*hr/mL
Standard Deviation 9110
|
166000000 ng*hr/mL
Standard Deviation 63600000
|
SECONDARY outcome
Timeframe: Days 1 and 5 of Cycles 1 and 2; Day 15 of Cycle 1Population: The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Outcome measures
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=3 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
n=4 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
n=2 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
n=3 Participants
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
n=2 Participants
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
n=2 Participants
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
n=2 Participants
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Ruxolitinib in Part 1
Ruxolitinib 15 mg Cycle 1 Day 1 n=1,0,2,1,2,0,2
|
1090 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
481 ng*hr/mL
Standard Deviation 243
|
729 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
662 ng*hr/mL
Standard Deviation 420
|
—
|
1220 ng*hr/mL
Standard Deviation 637
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Ruxolitinib in Part 1
Ruxolitinib 15 mg Cycle 1 Day 5 n=1,1,2,0,0,0,0
|
849 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
901 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
454 ng*hr/mL
Standard Deviation 212
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Ruxolitinib in Part 1
Ruxolitinib 5 mg Cycle 1 Day 1 n=0,0,2,1,0,0,0
|
—
|
—
|
344 ng*hr/mL
Standard Deviation 225
|
199 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Ruxolitinib in Part 1
Ruxolitinib 10 mg Cycle 1 Day 1 n=3,4,1,2,1,2,1
|
546 ng*hr/mL
Standard Deviation 412
|
673 ng*hr/mL
Standard Deviation 290
|
498 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
633 ng*hr/mL
Standard Deviation 393
|
440 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
336 ng*hr/mL
Standard Deviation 30.6
|
452 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Ruxolitinib in Part 1
Ruxolitinib 20 mg Cycle 1 Day 1 n=3,2,1,3,1,0,0
|
991 ng*hr/mL
Standard Deviation 183
|
616 ng*hr/mL
Standard Deviation 107
|
623 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
913 ng*hr/mL
Standard Deviation 451
|
887 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Ruxolitinib in Part 1
Ruxolitinib 25 mg Cycle 1 Day 1 n=0,0,0,1,0,0,1
|
—
|
—
|
—
|
188 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
859 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Ruxolitinib in Part 1
Ruxolitinib 5 mg Cycle 1 Day 5 n=0,0,2,0,0,0,0
|
—
|
—
|
245 ng*hr/mL
Standard Deviation 173
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Ruxolitinib in Part 1
Ruxolitinib 10 mg Cycle 1 Day 5 n=3,3,1,0,0,0,0,
|
465 ng*hr/mL
Standard Deviation 228
|
550 ng*hr/mL
Standard Deviation 307
|
441 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Ruxolitinib in Part 1
Ruxolitinib 20 mg Cycle 1 Day 5 n=2,4,1,0,0,0,0
|
872 ng*hr/mL
Standard Deviation 218
|
652 ng*hr/mL
Standard Deviation 218
|
482 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Ruxolitinib in Part 1
Ruxolitinib 5 mg Cycle 1 Day 15 n=0,0,0,1,0,0,0
|
—
|
—
|
—
|
289 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Ruxolitinib in Part 1
Ruxolitinib 10 mg Cycle 1 Day 15 n=0,0,0,2,0,0,0
|
—
|
—
|
—
|
592 ng*hr/mL
Standard Deviation 403
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Ruxolitinib in Part 1
Ruxolitinib 15 mg Cycle 1 Day 15 n=0,0,0,1,0,0,0,
|
—
|
—
|
—
|
518 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Ruxolitinib in Part 1
Ruxolitinib 20 mg Cycle 1 Day 15 n=0,0,0,3,0,0,0
|
—
|
—
|
—
|
957 ng*hr/mL
Standard Deviation 479
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Ruxolitinib in Part 1
Ruxolitinib 25 mg Cycle 1 Day 15 n=0,0,0,1,0,0,0
|
—
|
—
|
—
|
718 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Ruxolitinib in Part 1
Ruxolitinib 5 mg Cycle 2 Day 1 n=0,0,1,0,0,0,0
|
—
|
—
|
172 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Ruxolitinib in Part 1
Ruxolitinib 10 mg Cycle 2 Day 1 n=2,2,1,0,0,0,0
|
354 ng*hr/mL
Standard Deviation 101
|
507 ng*hr/mL
Standard Deviation 225
|
553 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Ruxolitinib in Part 1
Ruxolitinib 15 mg Cycle 2 Day 1 n=1,2,2,0,0,0,0
|
1040 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
1190 ng*hr/mL
Standard Deviation 214
|
334 ng*hr/mL
Standard Deviation 98.7
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Ruxolitinib in Part 1
Ruxolitinib 20 mg Cycle 2 Day 1 n=3,3,1,0,0,0,0
|
823 ng*hr/mL
Standard Deviation 206
|
727 ng*hr/mL
Standard Deviation 200
|
521 ng*hr/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 5 of Cycles 1 and 2 for siremadlin and Cycles 1 and 3 for crizanlizumab, sabatolimab, and NIS793; Days 1 and 15 of Cycle 1 for rineterkibPopulation: The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Outcome measures
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=6 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
n=9 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
n=5 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
n=9 Participants
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
n=5 Participants
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
n=2 Participants
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
n=4 Participants
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
|---|---|---|---|---|---|---|---|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Cycle 1 Day 1 n=6,9,5,9,5,2,4
|
118 ng/mL
Standard Deviation 32.8
|
207 ng/mL
Standard Deviation 122
|
290 ng/mL
Standard Deviation 56.1
|
469 ng/mL
Standard Deviation 358
|
114000 ng/mL
Standard Deviation 36400
|
131 ng/mL
Standard Deviation 17.7
|
439000 ng/mL
Standard Deviation 56100
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Cycle 1 Day 5 n=6,7,5,0,0,0,0
|
161 ng/mL
Standard Deviation 78.0
|
284 ng/mL
Standard Deviation 138
|
336 ng/mL
Standard Deviation 109
|
—
|
—
|
—
|
—
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Cycle 2 Day 1 n=5,6,3,0,0,0,0
|
131 ng/mL
Standard Deviation 57.9
|
142 ng/mL
Standard Deviation 102
|
268 ng/mL
Standard Deviation 15.0
|
—
|
—
|
—
|
—
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Cycle 2 Day 5 n=3,5,3,0,0,0,0
|
103 ng/mL
Standard Deviation 34.1
|
193 ng/mL
Standard Deviation 95.0
|
228 ng/mL
Standard Deviation 58.3
|
—
|
—
|
—
|
—
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Cycle 1 Day 15 n=0,0,0,9,0,0,0
|
—
|
—
|
—
|
987 ng/mL
Standard Deviation 621
|
—
|
—
|
—
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Cycle 3 Day 1 n=0,0,0,0,5,2,3
|
—
|
—
|
—
|
—
|
114000 ng/mL
Standard Deviation 56600
|
150 ng/mL
Standard Deviation 33.2
|
743000 ng/mL
Standard Deviation 314000
|
SECONDARY outcome
Timeframe: Days 1 and 5 of Cycles 1 and 2; Day 15 of Cycle 1Population: The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Outcome measures
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=3 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
n=4 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
n=2 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
n=3 Participants
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
n=2 Participants
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
n=2 Participants
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
n=2 Participants
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
|---|---|---|---|---|---|---|---|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Ruxolitinib in Part 1
Ruxolitinib 10 mg Cycle 1 Day 1 n=3,4,1,2,1,2,1
|
184 ng/mL
Standard Deviation 159
|
209 ng/mL
Standard Deviation 20.8
|
108 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
195 ng/mL
Standard Deviation 41.0
|
191 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
118 ng/mL
Standard Deviation 33.0
|
132 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Ruxolitinib in Part 1
Ruxolitinib 15 mg Cycle 1 Day 1 n=1,0,2,1,2,0,2
|
334 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
119 ng/mL
Standard Deviation 76.2
|
193 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
185 ng/mL
Standard Deviation 120
|
—
|
254 ng/mL
Standard Deviation 73.5
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Ruxolitinib in Part 1
Ruxolitinib 20 mg Cycle 1 Day 1 n=3,2,1,3,1,0,0
|
310 ng/mL
Standard Deviation 131
|
184 ng/mL
Standard Deviation 14.8
|
232 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
332 ng/mL
Standard Deviation 33.5
|
221 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Ruxolitinib in Part 1
Ruxolitinib 25 mg Cycle 1 Day 1 n=0,0,0,1,0,0,1
|
—
|
—
|
—
|
46.0 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
224 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Ruxolitinib in Part 1
Ruxolitinib 5 mg Cycle 1 Day 5 n=0,0,2,0,0,0,0
|
—
|
—
|
74.8 ng/mL
Standard Deviation 13.5
|
—
|
—
|
—
|
—
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Ruxolitinib in Part 1
Ruxolitinib 10 mg Cycle 1 Day 5 n=3,3,1,0,0,0,0
|
152 ng/mL
Standard Deviation 55.3
|
149 ng/mL
Standard Deviation 67.6
|
107 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Ruxolitinib in Part 1
Ruxolitinib 15 mg Cycle 1 Day 5 n=1,1,2,0,0,0,0
|
252 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
264 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
172 ng/mL
Standard Deviation 96.9
|
—
|
—
|
—
|
—
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Ruxolitinib in Part 1
Ruxolitinib 20 mg Cycle 1 Day 5 n=2,4,1,0,0,0,0
|
211 ng/mL
Standard Deviation 48.8
|
232 ng/mL
Standard Deviation 104
|
180 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Ruxolitinib in Part 1
Ruxolitinib 5 mg Cycle 1 Day 15 n=0,0,0,1,0,0,0
|
—
|
—
|
—
|
95.4 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Ruxolitinib in Part 1
Ruxolitinib 15 mg Cycle 1 Day 15 n=0,0,0,1,0,0,0
|
—
|
—
|
—
|
126 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Ruxolitinib in Part 1
Ruxolitinib 20 mg Cycle 1 Day 15 n=0,0,0,3,0,0,0
|
—
|
—
|
—
|
369 ng/mL
Standard Deviation 83.7
|
—
|
—
|
—
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Ruxolitinib in Part 1
Ruxolitinib 25 mg Cycle 1 Day 15 n=0,0,0,1,0,0,0
|
—
|
—
|
—
|
323 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Ruxolitinib in Part 1
Ruxolitinib 5 mg Cycle 2 Day 1 n=0,0,1,0,0,0,0
|
—
|
—
|
82.1 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Ruxolitinib in Part 1
Ruxolitinib 10 mg Cycle 2 Day 1 n=2,2,1,0,0,0,0
|
119 ng/mL
Standard Deviation 66.7
|
165 ng/mL
Standard Deviation 29.7
|
90.5 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Ruxolitinib in Part 1
Ruxolitinib 15 mg Cycle 2 Day 1 n=1,2,2,0,0,0,0
|
260 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
337 ng/mL
Standard Deviation 70.7
|
100 ng/mL
Standard Deviation 68.9
|
—
|
—
|
—
|
—
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Ruxolitinib in Part 1
Ruxolitinib 20 mg Cycle 2 Day 1 n=3,3,1,0,0,0,0
|
257 ng/mL
Standard Deviation 71.0
|
176 ng/mL
Standard Deviation 66.0
|
241 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Ruxolitinib in Part 1
Ruxolitinib 5 mg Cycle 1 Day 1 n=0,0,2,1,0,0,0
|
—
|
—
|
93.3 ng/mL
Standard Deviation 26.5
|
67.4 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
|
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Ruxolitinib in Part 1
Ruxolitinib 10 mg Cycle 1 Day 15 n=0,0,0,2,0,0,0
|
—
|
—
|
—
|
158 ng/mL
Standard Deviation 68.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 5 of Cycles 1 and 2 for siremadlin and Cycles 1 and 3 for crizanlizumab, sabatolimab, and NIS793; Days 1 and 15 of Cycle 1 for rineterkibPopulation: The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Outcome measures
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=6 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
n=9 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
n=5 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
n=9 Participants
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
n=5 Participants
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
n=2 Participants
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
n=4 Participants
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Cycle 1 Day 1 n=6,9,5,9,5,2,4
|
2.52 hours
Interval 1.83 to 23.5
|
3.00 hours
Interval 1.92 to 7.45
|
3.93 hours
Interval 2.0 to 8.0
|
3.92 hours
Interval 1.98 to 24.0
|
1.82 hours
Interval 1.5 to 2.27
|
1.84 hours
Interval 1.67 to 2.0
|
2.00 hours
Interval 1.95 to 2.98
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Cycle 1 Day 5 n=6,7,5,0,0,0,0
|
3.44 hours
Interval 1.83 to 4.07
|
2.90 hours
Interval 2.0 to 3.97
|
2.87 hours
Interval 1.88 to 3.03
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Cycle 2 Day 1 n=5,6,3,0,0,0,0
|
1.95 hours
Interval 0.98 to 4.1
|
3.92 hours
Interval 2.83 to 23.9
|
2.88 hours
Interval 2.08 to 7.07
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Cycle 2 Day 5 n=3,5,3,0,0,0,0
|
3.00 hours
Interval 2.95 to 3.17
|
2.93 hours
Interval 2.75 to 3.17
|
3.02 hours
Interval 2.92 to 3.08
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Cycle 1 Day 15 n=0,0,0,9,0,0,0
|
—
|
—
|
—
|
2.50 hours
Interval 0.5 to 4.0
|
—
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Cycle 3 Day 1 n=0,0,0,0,5,2,3
|
—
|
—
|
—
|
—
|
1.65 hours
Interval 0.75 to 2.13
|
2.01 hours
Interval 1.85 to 2.17
|
1.97 hours
Interval 1.92 to 2.33
|
SECONDARY outcome
Timeframe: Days 1 and 5 of Cycles 1 and 2; Day 15 of Cycle 1Population: The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Outcome measures
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=3 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
n=4 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
n=2 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
n=3 Participants
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
n=2 Participants
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
n=2 Participants
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
n=2 Participants
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Ruxolitinib in Part 1
Ruxolitinib 10 mg Cycle 1 Day 1 n=3,4,1,2,1,2,1
|
0.550 hours
Interval 0.33 to 6.18
|
0.775 hours
Interval 0.5 to 1.08
|
0.500 hours
Interval 0.5 to 0.5
|
0.485 hours
Interval 0.47 to 0.5
|
0.580 hours
Interval 0.58 to 0.58
|
0.460 hours
Interval 0.0 to 0.92
|
1.67 hours
Interval 1.67 to 1.67
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Ruxolitinib in Part 1
Ruxolitinib 15 mg Cycle 1 Day 1 n=1,0,2,1,2,0,2
|
0.650 hours
Interval 0.65 to 0.65
|
—
|
1.96 hours
Interval 1.92 to 2.0
|
0.420 hours
Interval 0.42 to 0.42
|
1.80 hours
Interval 1.75 to 1.85
|
—
|
2.42 hours
Interval 1.08 to 3.75
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Ruxolitinib in Part 1
Ruxolitinib 20 mg Cycle 1 Day 1 n=3,2,1,3,1,0,0
|
0.530 hours
Interval 0.5 to 1.0
|
1.54 hours
Interval 1.08 to 2.0
|
1.00 hours
Interval 1.0 to 1.0
|
0.450 hours
Interval 0.42 to 1.03
|
1.17 hours
Interval 1.17 to 1.17
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Ruxolitinib in Part 1
Ruxolitinib 20 mg Cycle 1 Day 5 n=2,4,1,0,0,0,0
|
0.925 hours
Interval 0.85 to 1.0
|
1.00 hours
Interval 0.92 to 1.08
|
0.830 hours
Interval 0.83 to 0.83
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Ruxolitinib in Part 1
Ruxolitinib 5 mg Cycle 1 Day 15 n=0,0,0,1,0,0,0
|
—
|
—
|
—
|
0.500 hours
Interval 0.5 to 0.5
|
—
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Ruxolitinib in Part 1
Ruxolitinib 10 mg Cycle 1 Day 15 n=0,0,0,2,0,0,0
|
—
|
—
|
—
|
1.98 hours
Interval 1.95 to 2.0
|
—
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Ruxolitinib in Part 1
Ruxolitinib 15 mg Cycle 1 Day 15 n=0,0,0,1,0,0,0
|
—
|
—
|
—
|
0.500 hours
Interval 0.5 to 0.5
|
—
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Ruxolitinib in Part 1
Ruxolitinib 20 mg Cycle 1 Day 15 n=0,0,0,3,0,0,0
|
—
|
—
|
—
|
0.650 hours
Interval 0.5 to 1.0
|
—
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Ruxolitinib in Part 1
Ruxolitinib 25 mg Cycle 1 Day 15 n=0,0,0,1,0,0,0
|
—
|
—
|
—
|
0.500 hours
Interval 0.5 to 0.5
|
—
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Ruxolitinib in Part 1
Ruxolitinib 5 mg Cycle 2 Day 1 n=0,0,1,0,0,0,0
|
—
|
—
|
0.900 hours
Interval 0.9 to 0.9
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Ruxolitinib in Part 1
Ruxolitinib 10 mg Cycle 2 Day 1 n=2,2,1,0,0,0,0
|
0.895 hours
Interval 0.87 to 0.92
|
1.00 hours
Interval 0.92 to 1.08
|
2.00 hours
Interval 2.0 to 2.0
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Ruxolitinib in Part 1
Ruxolitinib 15 mg Cycle 2 Day 1 n=1,2,2,0,0,0,0
|
1.05 hours
Interval 1.05 to 1.05
|
1.46 hours
Interval 1.0 to 1.92
|
4.00 hours
Interval 0.92 to 7.07
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Ruxolitinib in Part 1
Ruxolitinib 5 mg Cycle 1 Day 1 n=0,0,2,1,0,0,0
|
—
|
—
|
0.960 hours
Interval 0.92 to 1.0
|
0.500 hours
Interval 0.5 to 0.5
|
—
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Ruxolitinib in Part 1
Ruxolitinib 25 mg Cycle 1 Day 1 n=0,0,0,1,0,0,1
|
—
|
—
|
—
|
0.00 hours
Interval 0.0 to 0.0
|
—
|
—
|
2.00 hours
Interval 2.0 to 2.0
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Ruxolitinib in Part 1
Ruxolitinib 5 mg Cycle 1 Day 5 n=0,0,2,0,0,0,0
|
—
|
—
|
0.960 hours
Interval 0.92 to 1.0
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Ruxolitinib in Part 1
Ruxolitinib 10 mg Cycle 1 Day 5 n=3,3,1,0,0,0,0
|
1.00 hours
Interval 0.83 to 2.02
|
0.980 hours
Interval 0.92 to 2.03
|
1.00 hours
Interval 1.0 to 1.0
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Ruxolitinib in Part 1
Ruxolitinib 15 mg Cycle 1 Day 5 n=1,1,2,0,0,0,0
|
0.970 hours
Interval 0.97 to 0.97
|
0.830 hours
Interval 0.83 to 0.83
|
0.955 hours
Interval 0.83 to 1.08
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Ruxolitinib in Part 1
Ruxolitinib 20 mg Cycle 2 Day 1 n=3,3,1,0,0,0,0
|
0.980 hours
Interval 0.88 to 1.02
|
1.02 hours
Interval 1.0 to 4.0
|
0.930 hours
Interval 0.93 to 0.93
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 1 and 2; Day 6 of Cycle 1; Days 2 and 5 of Cycles 1, 2, 3, 4, 5, and 6. Each cycle was 28 days.Population: The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Outcome measures
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=7 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
n=10 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
n=5 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
|---|---|---|---|---|---|---|---|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 1 Day 1, 2 hr n=6,9,5
|
104 ng/mL
Standard Deviation 53.3
|
146 ng/mL
Standard Deviation 95.1
|
199 ng/mL
Standard Deviation 139
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 1 Day 1, 3 hr n=6,9,4
|
102 ng/mL
Standard Deviation 51.8
|
178 ng/mL
Standard Deviation 96.3
|
192 ng/mL
Standard Deviation 137
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 1 Day 1, 4 hr n=6,9,5
|
92.9 ng/mL
Standard Deviation 44.0
|
181 ng/mL
Standard Deviation 116
|
201 ng/mL
Standard Deviation 109
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 1 Day 1, 8 hr n=6,9,5
|
75.7 ng/mL
Standard Deviation 36.9
|
146 ng/mL
Standard Deviation 77.0
|
212 ng/mL
Standard Deviation 55.5
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 1 Day 2, 24 hr n=6,10,4
|
42.0 ng/mL
Standard Deviation 23.7
|
59.7 ng/mL
Standard Deviation 49.4
|
95.3 ng/mL
Standard Deviation 41.2
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 1 Day 5, 0 hr (pre-dose) n=6,7,5
|
43.5 ng/mL
Standard Deviation 42.2
|
88.4 ng/mL
Standard Deviation 73.6
|
77.6 ng/mL
Standard Deviation 84.2
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 1 Day 5,1 hr n=6,6,5
|
72.9 ng/mL
Standard Deviation 28.3
|
171 ng/mL
Standard Deviation 89.8
|
155 ng/mL
Standard Deviation 123
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 1 Day 5, 2 hr n=6,7,5
|
127 ng/mL
Standard Deviation 63.7
|
260 ng/mL
Standard Deviation 128
|
324 ng/mL
Standard Deviation 112
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 1 Day 5, 3 hr n=6,7,5
|
144 ng/mL
Standard Deviation 74.6
|
260 ng/mL
Standard Deviation 130
|
333 ng/mL
Standard Deviation 108
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 1 Day 5, 4 hr n=5,7,5
|
133 ng/mL
Standard Deviation 67.4
|
226 ng/mL
Standard Deviation 111
|
295 ng/mL
Standard Deviation 97.9
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 1 Day 5, 8 hr n=7,8,3
|
110 ng/mL
Standard Deviation 54.3
|
160 ng/mL
Standard Deviation 83.1
|
247 ng/mL
Standard Deviation 126
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 1 Day 6, 24 hr n=7,8,5
|
45.4 ng/mL
Standard Deviation 35.9
|
75.1 ng/mL
Standard Deviation 66.5
|
72.2 ng/mL
Standard Deviation 90.5
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 2 Day 1, 0 hr (pre-dose) n=4,5,3
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 2 Day 1, 1 hr n=5,5,3
|
71.8 ng/mL
Standard Deviation 92.9
|
25.5 ng/mL
Standard Deviation 28.4
|
32.2 ng/mL
Standard Deviation 28.7
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 2 Day 1, 2 hr n=5,5,2
|
116 ng/mL
Standard Deviation 64.7
|
100 ng/mL
Standard Deviation 64.8
|
144 ng/mL
Standard Deviation 200
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 2 Day 1, 3 hr n=5,5,3
|
111 ng/mL
Standard Deviation 58.2
|
146 ng/mL
Standard Deviation 99.5
|
178 ng/mL
Standard Deviation 147
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 2 Day 1, 4 hr n=5,5,3
|
114 ng/mL
Standard Deviation 52.8
|
158 ng/mL
Standard Deviation 78.4
|
164 ng/mL
Standard Deviation 102
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 2 Day 1, 8 hr n=4,5,3
|
90.9 ng/mL
Standard Deviation 39.1
|
122 ng/mL
Standard Deviation 54.5
|
189 ng/mL
Standard Deviation 63.2
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 2 Day 2, 24 hr n=4,5,3
|
67.3 ng/mL
Standard Deviation 49.3
|
48.5 ng/mL
Standard Deviation 44.2
|
31.7 ng/mL
Standard Deviation 5.42
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 2 Day 5, 0 hr (pre-dose) n=4,7,3
|
24.3 ng/mL
Standard Deviation 23.8
|
42.5 ng/mL
Standard Deviation 50.8
|
29.2 ng/mL
Standard Deviation 6.67
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 4 Day 5, 0 hr (pre-dose) n=5,6,1
|
40.4 ng/mL
Standard Deviation 29.7
|
50.1 ng/mL
Standard Deviation 48.1
|
10.5 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 5 Day 2, 0 hr (pre-dose) n=6,4,4
|
40.0 ng/mL
Standard Deviation 29.3
|
146 ng/mL
Standard Deviation 180
|
49.2 ng/mL
Standard Deviation 25.1
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 5 Day 5, 0 hr (pre-dose) n=6,4,3
|
78.3 ng/mL
Standard Deviation 90.2
|
124 ng/mL
Standard Deviation 129
|
32.5 ng/mL
Standard Deviation 13.5
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 6 Day 2, 0 hr (pre-dose) n=5,2,1
|
48.0 ng/mL
Standard Deviation 28.2
|
60.2 ng/mL
Standard Deviation 37.0
|
16.4 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 1 Day 1, 0 hr (pre-dose) n=6,7,5
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 1 Day 1, 0.5 hr n=6,8,5
|
7.46 ng/mL
Standard Deviation 6.23
|
4.76 ng/mL
Standard Deviation 8.02
|
12.8 ng/mL
Standard Deviation 21.0
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 1 Day 1, 1 hr n=6,9,5
|
52.7 ng/mL
Standard Deviation 27.0
|
38.8 ng/mL
Standard Deviation 40.9
|
87.0 ng/mL
Standard Deviation 73.6
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 2 Day 5, 3 hr n=3,6,3
|
103 ng/mL
Standard Deviation 34.1
|
181 ng/mL
Standard Deviation 89.7
|
228 ng/mL
Standard Deviation 58.3
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 2 Day 6, 24 hr n=4,5,3
|
34.7 ng/mL
Standard Deviation 13.2
|
51.5 ng/mL
Standard Deviation 58.3
|
27.5 ng/mL
Standard Deviation 6.45
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 3 Day 2, 0 hr (pre-dose) n=3,4,4
|
43.5 ng/mL
Standard Deviation 16.5
|
79.1 ng/mL
Standard Deviation 96.9
|
39.2 ng/mL
Standard Deviation 20.5
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 3 Day 5, 0 hr (pre-dose) n=5,6,3
|
56.8 ng/mL
Standard Deviation 47.9
|
81.0 ng/mL
Standard Deviation 73.9
|
29.7 ng/mL
Standard Deviation 23.3
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 4 Day 2, 0 hr (pre-dose) n=5,5,1
|
36.3 ng/mL
Standard Deviation 21.7
|
63.0 ng/mL
Standard Deviation 52.4
|
10.9 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Siremadlin in Part 1
Cycle 6 Day 5, 0 hr (pre-dose) n=4,2,1
|
79.0 ng/mL
Standard Deviation 52.2
|
68.9 ng/mL
Standard Deviation 68.1
|
9.02 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 2, 15, and 16 of Cycle 1; Day 1 of Cycles 2, 3, 4, 5, and 6. Each cycle was 28 days.Population: The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Outcome measures
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=9 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
|---|---|---|---|---|---|---|---|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 1 Day 1, 0.5 hr n=9
|
68.3 ng/mL
Standard Deviation 68.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 1 Day 1, 1 hr n=8
|
235 ng/mL
Standard Deviation 343
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 1 Day 1, 2 hr n=8
|
340 ng/mL
Standard Deviation 229
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 1 Day 1, 3 hr n=9
|
352 ng/mL
Standard Deviation 244
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 1 Day 15, 1 hr n=n=9
|
735 ng/mL
Standard Deviation 620
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 1 Day 15, 2 hr n=8
|
749 ng/mL
Standard Deviation 512
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 1 Day 15, 3 hr n=8
|
789 ng/mL
Standard Deviation 616
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 1 Day 15, 4 hr n=8
|
771 ng/mL
Standard Deviation 484
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 1 Day 15, 8 hr n=9
|
633 ng/mL
Standard Deviation 403
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 1 Day 16, 24 hr n=8
|
528 ng/mL
Standard Deviation 618
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 1 Day 16, 0 hr (pre-dose) n=8
|
305 ng/mL
Standard Deviation 222
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 2 Day 1, 0 hr (pre-dose) n=9
|
314 ng/mL
Standard Deviation 171
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 3 Day 1, 0 hr (pre-dose) n=6
|
406 ng/mL
Standard Deviation 341
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 4 Day 1, 0 hr (pre-dose) n=5
|
402 ng/mL
Standard Deviation 364
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 5 Day 1, 0 hr (pre-dose) n=3
|
232 ng/mL
Standard Deviation 165
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 6 Day 1, 0 hr (pre-dose) n=3
|
340 ng/mL
Standard Deviation 125
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 1 Day 1, 0 hr (pre-dose) n=9
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 1 Day 1, 4 hr n=9
|
325 ng/mL
Standard Deviation 173
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 1 Day 1, 8 hr n=7
|
244 ng/mL
Standard Deviation 128
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 1 Day 2, 24 hr n=9
|
261 ng/mL
Standard Deviation 419
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 1 Day 2, 0 hr (pre-dose) n=8
|
234 ng/mL
Standard Deviation 440
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 1 Day 15, 0 hr (pre-dose) n=8
|
330 ng/mL
Standard Deviation 222
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Rineterkib in Part 1
Cycle 1 Day 15 0.5 hr n=8
|
581 ng/mL
Standard Deviation 464
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 2, 8, and 15 of Cycles 1, 2, and 3; Day 1 of Cycles 4, 5, 6, and 9. Each cycle was 28 days.Population: The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
EOI = end of infusion
Outcome measures
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=5 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
|---|---|---|---|---|---|---|---|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 1 Day 1, 0 H / PRE-INFUSION n=4
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 1 Day 1, 1H POST EOI n=5
|
114000 ng/mL
Standard Deviation 36400
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 1 Day 2, 24H POST START OF INFUSION n=4
|
78700 ng/mL
Standard Deviation 10500
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 1 Day 8, 168H POST START OF INFUSION n=5
|
28700 ng/mL
Standard Deviation 12200
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 1 Day 15, 336H POST START OF INFUSION n=5
|
9280 ng/mL
Standard Deviation 4540
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 1 Day 15, 0 H / PRE-INFUSION n=1
|
7710 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 2 Day 1, 0 H / PRE-INFUSION n=5
|
20700 ng/mL
Standard Deviation 8980
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 2 Day 1, 1H POST EOI n=5
|
135000 ng/mL
Standard Deviation 43100
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 2 Day 1, 336H POST START OF INFUSION n=1,
|
15500 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 3 Day 1, 672H POST START OF INFUSION n=5
|
8710 ng/mL
Standard Deviation 8350
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 6 Day 1, 0 H / PRE-INFUSION n=4
|
6930 ng/mL
Standard Deviation 8000
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 6 Day 1, 1H POST EOI n=4
|
128000 ng/mL
Standard Deviation 39600
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 9 Day 1, 0 H / PRE-INFUSION n=3
|
5500 ng/mL
Standard Deviation 9530
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 3 Day 1, 0 H / PRE-INFUSION n=5
|
8710 ng/mL
Standard Deviation 8350
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 3 Day 1, 1H POST EOI n=4
|
103000 ng/mL
Standard Deviation 59200
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 3 Day 2, 24H POST START OF INFUSION n=5
|
95500 ng/mL
Standard Deviation 42300
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 3 Day 8, 168H POST START OF INFUSION n=5
|
37100 ng/mL
Standard Deviation 19400
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 3 Day 15, 336H POST START OF INFUSION n=5
|
21000 ng/mL
Standard Deviation 17700
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 4 Day 1, 672H POST START OF INFUSION n=5
|
5900 ng/mL
Standard Deviation 6710
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 4 Day 1, 0 H / PRE-INFUSION n=5
|
5900 ng/mL
Standard Deviation 6710
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 4 Day 1, 1H POST EOI n=5
|
128000 ng/mL
Standard Deviation 33200
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 5 Day 1, 672H POST START OF INFUSION n=4
|
6780 ng/mL
Standard Deviation 7830
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 5 Day 1, 0 H / PRE-INFUSION n=4
|
6780 ng/mL
Standard Deviation 7830
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 5 Day 1, 1H POST EOI n=3
|
122000 ng/mL
Standard Deviation 29400
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Crizanlizumab in Part 1
Cycle 6 Day 1, 672H POST START OF INFUSION n=4
|
6930 ng/mL
Standard Deviation 8000
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 2, 8, and 15 of Cycles 1, 2, and 3; Day 1 of Cycles 4 and 5. Each cycle was 28 days.Population: The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
EOI = end of infusion
Outcome measures
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=2 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
|---|---|---|---|---|---|---|---|
|
Concentration Versus Time Profile for Sabatolimab in Part 1
Cycle 1 Day 1, 0 H / PRE-INFUSION n=2
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Sabatolimab in Part 1
Cycle 1 Day 1, 1H POST EOI n=1
|
143 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Sabatolimab in Part 1
Cycle 1 Day 2, 24H POST START OF INFUSION n=2
|
109 ng/mL
Standard Deviation 13.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Sabatolimab in Part 1
Cycle 1 Day 8, 168H POST START OF INFUSION n=1
|
57.0 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Sabatolimab in Part 1
Cycle 1 Day 15, 336H POST START OF INFUSION n=2
|
41.8 ng/mL
Standard Deviation 7.28
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Sabatolimab in Part 1
Cycle 2 Day 1, 672H POST START OF INFUSION n=2
|
16.1 ng/mL
Standard Deviation 9.16
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Sabatolimab in Part 1
Cycle 2 Day 1, 0 H / PRE-INFUSION n=2
|
16.1 ng/mL
Standard Deviation 9.16
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Sabatolimab in Part 1
Cycle 2 Day 1, 1H POST EOI n=1
|
126 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Sabatolimab in Part 1
Cycle 3 Day 1, 672H POST START OF INFUSION n=2
|
26.0 ng/mL
Standard Deviation 5.09
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Sabatolimab in Part 1
Cycle 3 Day 1, 0 H / PRE-INFUSION n=2
|
26.0 ng/mL
Standard Deviation 5.09
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Sabatolimab in Part 1
Cycle 3 Day 1, 1H POST EOI n=2
|
150 ng/mL
Standard Deviation 33.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Sabatolimab in Part 1
Cycle 3 Day 2, 24H POST START OF INFUSION n=2
|
125 ng/mL
Standard Deviation 10.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Sabatolimab in Part 1
Cycle 3 Day 8, 168H POST START OF INFUSION n=2
|
80.5 ng/mL
Standard Deviation 19.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Sabatolimab in Part 1
Cycle 3 Day 15, 336H POST START OF INFUSION n=2
|
58.0 ng/mL
Standard Deviation 12.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Sabatolimab in Part 1
Cycle 4 Day 1, 672H POST START OF INFUSION n=1
|
31.1 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Sabatolimab in Part 1
Cycle 4 Day 1, 0 H / PRE-INFUSION n=2
|
30.0 ng/mL
Standard Deviation 1.56
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Sabatolimab in Part 1
Cycle 4 Day 1, 1H POST EOI n=2
|
141 ng/mL
Standard Deviation 11.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Sabatolimab in Part 1
Cycle 5 Day 1, 0 H / PRE-INFUSION n=2
|
32.9 ng/mL
Standard Deviation 3.82
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Sabatolimab in Part 1
Cycle 5 Day 1, 1H POST EOI n=2
|
152 ng/mL
Standard Deviation 9.19
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 2, 4, 8, 11, and 15 of Cycles 1, 2, and 3; Day 1 of Cycles 4 and 5. Each cycle was 28 days.Population: The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
EOI = end of infusion
Outcome measures
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=4 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
|---|---|---|---|---|---|---|---|
|
Concentration Versus Time Profile for NIS793 in Part 1
Cycle 1 Day 1, 0 H / PRE-INFUSION n=4
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for NIS793 in Part 1
Cycle 1 Day 1, 1H POST EOI n=4
|
439000 ng/mL
Standard Deviation 56100
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for NIS793 in Part 1
Cycle 1 Day 2, 24H POST START OF INFUSION n=4
|
349000 ng/mL
Standard Deviation 52800
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for NIS793 in Part 1
Cycle 1 Day 4, 72H POST START OF INFUSION n=4
|
279000 ng/mL
Standard Deviation 48400
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for NIS793 in Part 1
Cycle 1 Day 8, 168H POST START OF INFUSION n=3
|
196000 ng/mL
Standard Deviation 31000
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for NIS793 in Part 1
Cycle 1 Day 11, 240H POST START OF INFUSION n=4
|
183000 ng/mL
Standard Deviation 45400
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for NIS793 in Part 1
Cycle 3 Day 2, 24H POST START OF INFUSION n=2
|
632000 ng/mL
Standard Deviation 17000
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for NIS793 in Part 1
Cycle 3 Day 4, 72H POST START OF INFUSION n=3
|
448000 ng/mL
Standard Deviation 114000
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for NIS793 in Part 1
Cycle 3 Day 8, 168H POST START OF INFUSION n=3
|
383000 ng/mL
Standard Deviation 103000
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for NIS793 in Part 1
Cycle 3 Day 11, 240H POST START OF INFUSION n=2
|
262000 ng/mL
Standard Deviation 93300
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for NIS793 in Part 1
Cycle 3 Day 15, 336H POST START OF INFUSION n=3
|
265000 ng/mL
Standard Deviation 51500
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for NIS793 in Part 1
Cycle 4 Day 1, 504H POST START OF INFUSION n=1
|
281000 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for NIS793 in Part 1
Cycle 4 Day 1, 0 H / PRE-INFUSION n=2
|
232000 ng/mL
Standard Deviation 70000
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for NIS793 in Part 1
Cycle 5 Day 1, 0 H / PRE-INFUSION n=1
|
280000 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for NIS793 in Part 1
Cycle 1 Day 15, 336H POST START OF INFUSION n=4
|
161000 ng/mL
Standard Deviation 37500
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for NIS793 in Part 1
Cycle 2 Day 1, 504H POST START OF INFUSION n=4
|
132000 ng/mL
Standard Deviation 33300
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for NIS793 in Part 1
Cycle 2 Day 1, 0 H / PRE-INFUSION n=4
|
132000 ng/mL
Standard Deviation 33300
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for NIS793 in Part 1
Cycle 3 Day 1, 0 H / PRE-INFUSION n=3
|
187000 ng/mL
Standard Deviation 61000
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for NIS793 in Part 1
Cycle 3 Day 1, 1H POST EOI n=3
|
743000 ng/mL
Standard Deviation 314000
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 2, 5, 6, and 15 of Cycles 1 and 2; Day 16 of Cycle 1; Days 1, 2, and 15 of Cycle 3; Days 1 and 5 of Cycles 4, 5, and 6. Each cycle was 28 days.Population: The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Outcome measures
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=7 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
n=8 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
n=6 Participants
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Rineterkib 200 mg
n=8 Participants
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
n=4 Participants
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
n=2 Participants
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
n=4 Participants
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
|---|---|---|---|---|---|---|---|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 1, 0 hr (pre-dose) n=6,6,5,7,3,2,4
|
34.7 ng/mL
Standard Deviation 17.8
|
21.3 ng/mL
Standard Deviation 14.5
|
11.8 ng/mL
Standard Deviation 13.4
|
20.1 ng/mL
Standard Deviation 16.1
|
12.9 ng/mL
Standard Deviation 6.31
|
51.2 ng/mL
Standard Deviation 61.0
|
37.9 ng/mL
Standard Deviation 48.4
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 1, 0.5 hr n=6,5,6,8,2,2,3
|
284 ng/mL
Standard Deviation 128
|
152 ng/mL
Standard Deviation 91.1
|
95.7 ng/mL
Standard Deviation 63.2
|
185 ng/mL
Standard Deviation 100
|
107 ng/mL
Standard Deviation 119
|
57.1 ng/mL
Standard Deviation 44.0
|
108 ng/mL
Standard Deviation 128
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 1, 1 hr n=6,6,6,7,2,2,3
|
240 ng/mL
Standard Deviation 78.9
|
167 ng/mL
Standard Deviation 51.7
|
124 ng/mL
Standard Deviation 64.5
|
192 ng/mL
Standard Deviation 106
|
65.7 ng/mL
Standard Deviation 59.9
|
110 ng/mL
Standard Deviation 44.1
|
164 ng/mL
Standard Deviation 140
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 1, 2 hr n=6,6,6,7,2,2,3
|
174 ng/mL
Standard Deviation 55.3
|
143 ng/mL
Standard Deviation 48.6
|
98.9 ng/mL
Standard Deviation 46.2
|
140 ng/mL
Standard Deviation 112
|
170 ng/mL
Standard Deviation 140
|
72.7 ng/mL
Standard Deviation 4.10
|
187 ng/mL
Standard Deviation 105
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 1, 3 hr n=6,6,5,8,2,2,3
|
125 ng/mL
Standard Deviation 36.6
|
114 ng/mL
Standard Deviation 42.1
|
62.4 ng/mL
Standard Deviation 31.1
|
97.4 ng/mL
Standard Deviation 75.7
|
124 ng/mL
Standard Deviation 91.0
|
54.4 ng/mL
Standard Deviation 10.4
|
184 ng/mL
Standard Deviation 77.9
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 1, 4 hr n=6,6,6,8,2,2,3
|
93.2 ng/mL
Standard Deviation 26.5
|
77.8 ng/mL
Standard Deviation 40.0
|
50.2 ng/mL
Standard Deviation 23.4
|
59.2 ng/mL
Standard Deviation 46.1
|
101 ng/mL
Standard Deviation 81.2
|
28.3 ng/mL
Standard Deviation 7.28
|
190 ng/mL
Standard Deviation 58.4
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 1, 8 hr n=6,6,6,8,4,2,3
|
51.6 ng/mL
Standard Deviation 18.7
|
32.2 ng/mL
Standard Deviation 19.1
|
24.0 ng/mL
Standard Deviation 15.0
|
29.9 ng/mL
Standard Deviation 19.8
|
39.5 ng/mL
Standard Deviation 29.2
|
7.75 ng/mL
Standard Deviation 1.52
|
44.4 ng/mL
Standard Deviation 35.3
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 2, 0 hr (pre-dose) n=7,6,4,8,1,1,0
|
18.2 ng/mL
Standard Deviation 13.0
|
13.4 ng/mL
Standard Deviation 11.1
|
11.2 ng/mL
Standard Deviation 16.2
|
17.6 ng/mL
Standard Deviation 19.9
|
30.3 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
0 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 5, 4 hr n=6,8,6,0,0,0,0
|
81.4 ng/mL
Standard Deviation 38.4
|
71.2 ng/mL
Standard Deviation 30.1
|
34.1 ng/mL
Standard Deviation 16.1
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 5, 8 hr n=6,8,4,0,0,0,0
|
37.6 ng/mL
Standard Deviation 22.6
|
22.9 ng/mL
Standard Deviation 13.7
|
16.2 ng/mL
Standard Deviation 13.4
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 2 Day 1, 0 hr (pre-dose) n=6,7,5,8,4,2,3
|
25.9 ng/mL
Standard Deviation 23.4
|
19.3 ng/mL
Standard Deviation 18.8
|
11.4 ng/mL
Standard Deviation 20.7
|
45.7 ng/mL
Standard Deviation 108
|
13.7 ng/mL
Standard Deviation 4.84
|
28.4 ng/mL
Standard Deviation 39.1
|
65.1 ng/mL
Standard Deviation 88.9
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 2 Day 1, 1 hr n=6,7,5,0,0,0,0
|
212 ng/mL
Standard Deviation 89.8
|
186 ng/mL
Standard Deviation 113
|
114 ng/mL
Standard Deviation 82.4
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 2 Day 1, 2 hr n=6,7,4,0,0,0,0
|
144 ng/mL
Standard Deviation 76.0
|
165 ng/mL
Standard Deviation 82.2
|
56.2 ng/mL
Standard Deviation 30.9
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 2 Day 1, 3 hr n=6,7,5,0,0,0,0
|
108 ng/mL
Standard Deviation 50.8
|
127 ng/mL
Standard Deviation 61.7
|
50.3 ng/mL
Standard Deviation 26.4
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 2 Day 1, 4 hr n=5,7,5,0,0,0,0
|
89.9 ng/mL
Standard Deviation 39.8
|
106 ng/mL
Standard Deviation 39.5
|
45.6 ng/mL
Standard Deviation 25.8
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 2 Day 1, 8 hr n=4,6,5,0,0,0,0
|
47.3 ng/mL
Standard Deviation 31.5
|
45.8 ng/mL
Standard Deviation 19.4
|
30.9 ng/mL
Standard Deviation 28.1
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 2 Day 2, 0 hr (pre-dose) n=3,6,5,0,0,0,0
|
74.0 ng/mL
Standard Deviation 62.3
|
19.2 ng/mL
Standard Deviation 19.7
|
13.9 ng/mL
Standard Deviation 20.5
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 2 Day 5, 0 hr (pre-dose) n=3,8,4,0,0,0,0
|
15.4 ng/mL
Standard Deviation 6.29
|
15.2 ng/mL
Standard Deviation 11.3
|
4.45 ng/mL
Standard Deviation 4.57
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 2 Day 6, 0 hr (pre-dose) n=4,5,4,0,0,0,0
|
7.36 ng/mL
Standard Deviation 7.32
|
46.8 ng/mL
Standard Deviation 80.0
|
2.40 ng/mL
Standard Deviation 2.74
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 2 Day 15, 0 hr (pre-dose) n=6,8,3,0,1,2,0
|
22.4 ng/mL
Standard Deviation 17.2
|
22.1 ng/mL
Standard Deviation 22.7
|
1.93 ng/mL
Standard Deviation 1.65
|
—
|
63.6 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
7.95 ng/mL
Standard Deviation 8.14
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 3 Day 1, 0 hr (pre-dose) n=7,7,4,6,4,2,2
|
24.2 ng/mL
Standard Deviation 15.5
|
23.2 ng/mL
Standard Deviation 21.8
|
4.50 ng/mL
Standard Deviation 4.03
|
11.1 ng/mL
Standard Deviation 10.9
|
12.0 ng/mL
Standard Deviation 6.36
|
2.44 ng/mL
Standard Deviation 1.46
|
84.6 ng/mL
Standard Deviation 96.8
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 3 Day 2, 0 hr (pre-dose) n=5,6,3,0,0,0,0
|
12.6 ng/mL
Standard Deviation 13.9
|
31.9 ng/mL
Standard Deviation 38.9
|
2.33 ng/mL
Standard Deviation 1.57
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 3 Day 15, 0 hr (pre-dose) n=5,5,2,0,4,2,0
|
18.7 ng/mL
Standard Deviation 18.4
|
45.2 ng/mL
Standard Deviation 41.5
|
3.95 ng/mL
Standard Deviation 4.10
|
—
|
10.9 ng/mL
Standard Deviation 6.89
|
12.5 ng/mL
Standard Deviation 9.14
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 4 Day 1, 0 hr (pre-dose) n=7,5,3,5,4,1,1
|
17.5 ng/mL
Standard Deviation 18.2
|
20.9 ng/mL
Standard Deviation 22.2
|
4.53 ng/mL
Standard Deviation 6.44
|
18.2 ng/mL
Standard Deviation 33.8
|
14.0 ng/mL
Standard Deviation 7.81
|
2.94 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
24.4 ng/mL
Standard Deviation NA
Standard deviation was not calculable due to the single data point.
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 5 Day 1, 0 hr (pre-dose) n=7,6,4,3,3,0,0
|
16.4 ng/mL
Standard Deviation 16.1
|
12.7 ng/mL
Standard Deviation 12.0
|
5.30 ng/mL
Standard Deviation 5.94
|
10.3 ng/mL
Standard Deviation 13.6
|
20.1 ng/mL
Standard Deviation 23.0
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 5 Day 5, 0 hr (pre-dose) n=5,3,3,0,0,0,0
|
26.6 ng/mL
Standard Deviation 16.4
|
9.54 ng/mL
Standard Deviation 13.2
|
2.79 ng/mL
Standard Deviation 2.46
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 6 Day 1, 0 hr (pre-dose) n=4,4,2,3,3,0,0
|
15.8 ng/mL
Standard Deviation 19.5
|
17.0 ng/mL
Standard Deviation 19.7
|
0.608 ng/mL
Standard Deviation 0.0672
|
21.9 ng/mL
Standard Deviation 23.2
|
27.3 ng/mL
Standard Deviation 32.8
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 5, 0 hr (pre-dose) n=6,8,6,0,0,0,0
|
15.5 ng/mL
Standard Deviation 13.9
|
14.7 ng/mL
Standard Deviation 14.0
|
9.33 ng/mL
Standard Deviation 10.6
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 5, 1 hr n=6,7,6,0,0,0,0
|
160 ng/mL
Standard Deviation 79.5
|
221 ng/mL
Standard Deviation 83.7
|
130 ng/mL
Standard Deviation 66.6
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 5, 2 hr n=6,8,6,0,0,0,0
|
149 ng/mL
Standard Deviation 64.0
|
140 ng/mL
Standard Deviation 45.6
|
90.0 ng/mL
Standard Deviation 41.4
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 5, 3 hr n=6,8,6,0,0,0,0
|
104 ng/mL
Standard Deviation 45.2
|
100 ng/mL
Standard Deviation 39.1
|
61.8 ng/mL
Standard Deviation 31.7
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 6, 0 hr (pre-dose) n=6,7,5,0,0,0,0
|
11.5 ng/mL
Standard Deviation 12.1
|
37.8 ng/mL
Standard Deviation 63.4
|
6.28 ng/mL
Standard Deviation 9.31
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 15, 0 hr (pre-dose) n=7,8,4,7,3,2,0
|
23.2 ng/mL
Standard Deviation 34.0
|
23.6 ng/mL
Standard Deviation 19.8
|
11.2 ng/mL
Standard Deviation 17.4
|
11.9 ng/mL
Standard Deviation 14.2
|
12.6 ng/mL
Standard Deviation 10.1
|
4.06 ng/mL
Standard Deviation 2.28
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 15, 0.5 hr n=0,0,0,7,0,0,0
|
—
|
—
|
—
|
231 ng/mL
Standard Deviation 115
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 15, 1 hr n=0,0,0,8,0,0,0
|
—
|
—
|
—
|
194 ng/mL
Standard Deviation 139
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 15, 2 hr n=0,0,0,7,0,0,0
|
—
|
—
|
—
|
126 ng/mL
Standard Deviation 58.7
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 15, 3 hr n=0,0,0,7,0,0,0
|
—
|
—
|
—
|
103 ng/mL
Standard Deviation 59.6
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 15, 4 hr n=0,0,0,7,0,0,0
|
—
|
—
|
—
|
76.3 ng/mL
Standard Deviation 53.5
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 15, 8 hr n=0,0,0,8,0,0,0
|
—
|
—
|
—
|
27.9 ng/mL
Standard Deviation 21.7
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 1 Day 16, 0 hr (pre-dose) n=0,0,0,6,0,0,0
|
—
|
—
|
—
|
14.4 ng/mL
Standard Deviation 15.2
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 4 Day 5, 0 hr (pre-dose) n=5,6,3,0,0,0,0
|
13.6 ng/mL
Standard Deviation 13.7
|
9.12 ng/mL
Standard Deviation 13.5
|
7.99 ng/mL
Standard Deviation 11.4
|
—
|
—
|
—
|
—
|
|
Concentration Versus Time Profile for Ruxolitinib in Part 1
Cycle 6 Day 5, 0 hr (pre-dose) n=3,4,2,0,0,0,0
|
24.8 ng/mL
Standard Deviation 19.9
|
11.5 ng/mL
Standard Deviation 8.34
|
0.957 ng/mL
Standard Deviation 0.528
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1: Ruxolitinib + Siremadlin 20 mg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 1: Ruxolitinib + Siremadlin 30 mg
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 1: Ruxolitinib + Siremadlin 40 mg
Serious events: 4 serious events
Other events: 6 other events
Deaths: 3 deaths
Part 1: Ruxolitinib + Siremadlin Total
Serious events: 9 serious events
Other events: 23 other events
Deaths: 3 deaths
Part 1: Ruxolitinib + Rineterkib 200 mg
Serious events: 3 serious events
Other events: 9 other events
Deaths: 1 deaths
Part 1: Ruxolitinib + Crizanlizumab
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1: Ruxolitinib + Sabatolimab
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: Ruxolitinib + NIS793
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2: Ruxolitinib
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
All Subjects
Serious events: 15 serious events
Other events: 43 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=7 participants at risk
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
n=10 participants at risk
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
n=6 participants at risk
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin Total
n=23 participants at risk
Total
|
Part 1: Ruxolitinib + Rineterkib 200 mg
n=9 participants at risk
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
n=6 participants at risk
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
n=2 participants at risk
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
n=4 participants at risk
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
Part 2: Ruxolitinib
n=1 participants at risk
Existing stable dose of ruxolitinib as control for Part 2
|
All Subjects
n=45 participants at risk
All Subjects
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
50.0%
1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
General disorders
Pyrexia
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Infections and infestations
COVID-19
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
50.0%
1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Infections and infestations
Infection
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Injury, poisoning and procedural complications
Product administration error
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Investigations
Body temperature increased
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Skin and subcutaneous tissue disorders
Neutrophilic dermatosis
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
Other adverse events
| Measure |
Part 1: Ruxolitinib + Siremadlin 20 mg
n=7 participants at risk
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 30 mg
n=10 participants at risk
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin 40 mg
n=6 participants at risk
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Siremadlin Total
n=23 participants at risk
Total
|
Part 1: Ruxolitinib + Rineterkib 200 mg
n=9 participants at risk
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Crizanlizumab
n=6 participants at risk
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + Sabatolimab
n=2 participants at risk
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
|
Part 1: Ruxolitinib + NIS793
n=4 participants at risk
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
|
Part 2: Ruxolitinib
n=1 participants at risk
Existing stable dose of ruxolitinib as control for Part 2
|
All Subjects
n=45 participants at risk
All Subjects
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Vascular disorders
Hypertension
|
57.1%
4/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
17.4%
4/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
5/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.7%
2/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Skin and subcutaneous tissue disorders
Trichodysplasia spinulosa
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Vascular disorders
Angiopathy
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
42.9%
3/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
70.0%
7/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
83.3%
5/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
65.2%
15/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
50.0%
2/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
42.2%
19/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.7%
2/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
80.0%
8/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
50.0%
3/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
47.8%
11/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
24.4%
11/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
70.0%
7/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
100.0%
6/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
60.9%
14/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
22.2%
2/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
100.0%
2/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
42.2%
19/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Cardiac disorders
Sinus bradycardia
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Eye disorders
Dry eye
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Eye disorders
Eye pain
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Eye disorders
Macular oedema
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Eye disorders
Photopsia
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Eye disorders
Presbyopia
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Eye disorders
Retinopathy
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
22.2%
2/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Eye disorders
Serous retinopathy
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Eye disorders
Visual impairment
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.7%
2/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.7%
2/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
20.0%
2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
17.4%
4/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
5/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
42.9%
3/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
20.0%
2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
21.7%
5/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
66.7%
6/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
33.3%
2/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
28.9%
13/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Gastrointestinal disorders
Flatulence
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Gastrointestinal disorders
Nausea
|
85.7%
6/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
40.0%
4/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
50.0%
3/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
56.5%
13/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
33.3%
3/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
33.3%
2/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
40.0%
18/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
20.0%
2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
13.0%
3/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
5/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
General disorders
Asthenia
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
33.3%
3/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.9%
4/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
General disorders
Chest discomfort
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
General disorders
Chest pain
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
33.3%
2/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
General disorders
Chills
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
General disorders
Discomfort
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
General disorders
Fatigue
|
71.4%
5/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
33.3%
2/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
34.8%
8/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
17.8%
8/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
General disorders
Malaise
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
General disorders
Mucosal inflammation
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
General disorders
Oedema peripheral
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
13.0%
3/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.9%
4/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
General disorders
Pyrexia
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
30.0%
3/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
33.3%
2/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
21.7%
5/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
17.8%
8/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Infections and infestations
COVID-19
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
20.0%
2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
13.0%
3/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Infections and infestations
Candida infection
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Infections and infestations
Eye infection
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Infections and infestations
Furuncle
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
28.6%
2/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.7%
2/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Infections and infestations
Wound infection
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Investigations
Amylase increased
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.7%
2/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Investigations
Blood creatine phosphokinase increased
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
22.2%
2/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Investigations
Blood folate decreased
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Investigations
Blood potassium increased
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Investigations
Cardiac murmur
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Investigations
Heart rate decreased
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Investigations
Heart sounds abnormal
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Investigations
Lipase increased
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.7%
2/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Investigations
Neutrophil count decreased
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Investigations
Platelet count decreased
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Investigations
Weight increased
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.7%
2/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
42.9%
3/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
13.0%
3/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.9%
4/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.7%
2/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
20.0%
2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
17.4%
4/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
13.3%
6/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
22.2%
2/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
33.3%
2/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
5/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
22.2%
2/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
5/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.9%
4/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliac joint dysfunction
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.7%
2/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
33.3%
2/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.7%
2/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.9%
4/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Nervous system disorders
Headache
|
42.9%
3/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
17.4%
4/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
33.3%
2/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
15.6%
7/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Nervous system disorders
Migraine
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Nervous system disorders
Sciatica
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
33.3%
2/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.7%
2/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
33.3%
2/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
13.3%
6/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
2/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.7%
2/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.7%
2/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
33.3%
2/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.9%
4/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
50.0%
2/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.9%
4/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity mass
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
14.3%
1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
8.7%
2/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
22.2%
2/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
11.1%
1/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
4.3%
1/23 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/9 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
|
Additional Information
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 investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER