Trial Outcomes & Findings for A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects (NCT NCT01677741)
NCT ID: NCT01677741
Last Updated: 2021-11-24
Results Overview
The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Events, Serious Adverse Events and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
85 participants
Primary outcome timeframe
From study treatment start date till 28 days safety follow-up, assessed up to approximately 90 months
Results posted on
2021-11-24
Participant Flow
This study was conducted in 19 centers in eight participating countries: Australia (1), Canada (1), Denmark (1), Germany (1), France (4), Spain (1), United Kingdom (2), and United States (8).
Patients participated in only either Part 1 (Dose Escalation) or Part 2 (Tumor specific expansion) of the study.
Participant milestones
| Measure |
Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)
Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
|
Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)
Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
|
Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)
Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
|
Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)
Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
|
Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)
Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)
Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
10
|
8
|
6
|
17
|
28
|
11
|
2
|
|
Overall Study
DLT Evaluable Population
|
3
|
10
|
8
|
6
|
0
|
0
|
0
|
0
|
|
Overall Study
PK Population
|
3
|
10
|
8
|
6
|
17
|
28
|
11
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
10
|
8
|
6
|
17
|
28
|
11
|
2
|
Reasons for withdrawal
| Measure |
Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)
Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
|
Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)
Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
|
Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)
Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
|
Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)
Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
|
Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)
Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)
Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
7
|
5
|
4
|
11
|
20
|
4
|
2
|
|
Overall Study
Enrolled in a rollover study
|
0
|
3
|
2
|
1
|
6
|
6
|
7
|
0
|
|
Overall Study
Progressive disease
|
1
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects
Baseline characteristics by cohort
| Measure |
Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)
n=3 Participants
Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
|
Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)
n=10 Participants
Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
|
Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)
n=8 Participants
Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
|
Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)
n=6 Participants
Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
|
Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)
n=17 Participants
Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)
n=28 Participants
Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
n=11 Participants
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
n=2 Participants
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
72 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Continuous
|
9.33 Years
STANDARD_DEVIATION 5.132 • n=5 Participants
|
11.30 Years
STANDARD_DEVIATION 5.355 • n=7 Participants
|
6.58 Years
STANDARD_DEVIATION 5.445 • n=5 Participants
|
7.17 Years
STANDARD_DEVIATION 3.189 • n=4 Participants
|
9.65 Years
STANDARD_DEVIATION 5.195 • n=21 Participants
|
12.32 Years
STANDARD_DEVIATION 3.692 • n=10 Participants
|
5.52 Years
STANDARD_DEVIATION 3.390 • n=115 Participants
|
9.50 Years
STANDARD_DEVIATION 10.607 • n=24 Participants
|
9.46 Years
STANDARD_DEVIATION 5.051 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
35 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
50 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From study treatment start date till 28 days safety follow-up, assessed up to approximately 90 monthsPopulation: Safety population. Deaths occurring more than 28 days after the last dose of study drug were not included in the on-treatment deaths. All deaths included on-treatment deaths and those occurring more than 28 days after the last dose of study drug.
The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Events, Serious Adverse Events and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
Outcome measures
| Measure |
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg
All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)
n=3 Participants
Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)
n=10 Participants
Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
n=8 Participants
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
n=6 Participants
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg
All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
|---|---|---|---|---|---|---|---|---|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation)
All deaths
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation)
On-treatment deaths
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation)
Adverse Events (AEs)
|
—
|
3 Participants
|
10 Participants
|
8 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation)
AEs suspected to be drug related
|
—
|
3 Participants
|
10 Participants
|
8 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation)
Serious Adverse Events (SAEs)
|
—
|
0 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation)
SAEs suspected to be drug related
|
—
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation)
Fatal SAEs
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation)
Fatal SAEs suspected to be drug related
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation)
AEs leading to discontinuation
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation)
AEs requiring dose interruptions
|
—
|
1 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation)
AEs requiring dose reductions
|
—
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation)
AEs requiring dose reductions or interruptions
|
—
|
1 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 1 Day 1, Week 3 Day 15Population: Pharmacokinetic population. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax of dabrafenib was listed and summarized using descriptive statistics.
Outcome measures
| Measure |
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg
n=31 Participants
All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)
n=3 Participants
Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)
n=10 Participants
Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
n=8 Participants
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
n=6 Participants
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg
n=27 Participants
All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of Dabrafenib
Week 1 Day 1
|
1550 ng/mL
Geometric Coefficient of Variation 56.8
|
1820 ng/mL
Geometric Coefficient of Variation 38.0
|
1250 ng/mL
Geometric Coefficient of Variation 61.5
|
1250 ng/mL
Geometric Coefficient of Variation 529.9
|
1900 ng/mL
Geometric Coefficient of Variation 45.0
|
1340 ng/mL
Geometric Coefficient of Variation 82.6
|
—
|
—
|
|
Maximum Concentration (Cmax) of Dabrafenib
Week 3 Day 15
|
1310 ng/mL
Geometric Coefficient of Variation 49.4
|
1470 ng/mL
Geometric Coefficient of Variation 37.7
|
1260 ng/mL
Geometric Coefficient of Variation 48.1
|
1580 ng/mL
Geometric Coefficient of Variation 49.2
|
1710 ng/mL
Geometric Coefficient of Variation 56.4
|
1450 ng/mL
Geometric Coefficient of Variation 57.8
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 1 Day 1Population: Pharmacokinetic population. Due to limited dabrafenib PK data collected for Day 1 (up to 4 hours post-dose PK data only), no reliable AUC(0-t) and AUC (0-inf) PK parameters were collected/calculated.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUC(0-τ) and AUC(0-inf) of dabrafenib were to be listed and summarized using descriptive statistics.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 3 Day 15Population: Pharmacokinetic population. For each parameter, only participants with an evaluable PK sample collected were included in the analysis.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Pre-dose (trough) concentration (C tau) was to be listed and summarized using descriptive statistics for dabrafenib and its metabolites (hydroxy-dabrafenib \[GSK2285403\], carboxy-dabrafenib \[GSK2298683\], and desmethyl-dabrafenib \[GSK2167542\]).
Outcome measures
| Measure |
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg
n=29 Participants
All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)
n=3 Participants
Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)
n=10 Participants
Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
n=8 Participants
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
n=6 Participants
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg
n=26 Participants
All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
|---|---|---|---|---|---|---|---|---|
|
Pre-dose (Trough) Concentration (C Tau) of Dabrafenib and Its Metabolites
dabrafenib
|
22.8 ng/mL
Geometric Coefficient of Variation 209.5
|
11.9 ng/mL
Geometric Coefficient of Variation 276.5
|
39.8 ng/mL
Geometric Coefficient of Variation 176.1
|
50.7 ng/mL
Geometric Coefficient of Variation 121.0
|
11.0 ng/mL
Geometric Coefficient of Variation 67.5
|
42.7 ng/mL
Geometric Coefficient of Variation 135.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1 Day 1, Week 3 Day 15Population: Pharmacokinetic population. Due to limited dabrafenib PK data collected for Day 1 (up to 4 hours post-dose PK data only), no reliable AUC(0-t) PK parameters were collected/calculated.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Area under the time-concentration curve from time zero (pre-dose) to last time of quantifiable concentration (AUC\[0-t\]) dabrafenib metabolites (hydroxy-dabrafenib \[GSK2285403\], carboxy-dabrafenib \[GSK2298683\], and desmethyl-dabrafenib \[GSK2167542\]) were to be listed and summarized using descriptive statistics.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1 Day 1, Week 3 Day 15Population: Pharmacokinetic population. Due to limited dabrafenib PK data collected for Day 1 (up to 4 hours post-dose PK data only), no reliable AUC(0-tau) PK parameters were collected/calculated.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Area under the time-concentration curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-tau) of dabrafenib and its metabolites (hydroxy-dabrafenib \[GSK2285403\], carboxy-dabrafenib \[GSK2298683\], and desmethyl-dabrafenib \[GSK2167542\]) were to be listed and summarized using descriptive statistics.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1 Day 1, Week 3 Day 15Population: Pharmacokinetic population. Due to limited dabrafenib PK data collected for Day 1 (up to 4 hours post-dose PK data only), no reliable CL/F PK parameters were collected/calculated.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. CL/F of dabrafenib was to be listed and summarized using descriptive statistics.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1 Day 1, Week 3 Day 15Population: Pharmacokinetic population. For each parameter, only participants with an evaluable PK sample collected at each timepoint were included in the analysis.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax of dabrafenib metabolites (hydroxy-dabrafenib \[GSK2285403\], carboxy-dabrafenib \[GSK2298683\], and desmethyl-dabrafenib \[GSK2167542\]) were listed and summarized using descriptive statistics.
Outcome measures
| Measure |
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg
n=31 Participants
All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)
n=3 Participants
Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)
n=10 Participants
Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
n=8 Participants
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
n=6 Participants
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg
n=27 Participants
All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of Dabrafenib Metabolites
desmethyl-dabrafenib @ Week 1 Day 1
|
10.1 ng/mL
Geometric Coefficient of Variation 88.7
|
13.0 ng/mL
Geometric Coefficient of Variation 27.3
|
6.55 ng/mL
Geometric Coefficient of Variation 80.5
|
15.4 ng/mL
Geometric Coefficient of Variation 103.9
|
23.7 ng/mL
Geometric Coefficient of Variation 53.8
|
10.7 ng/mL
Geometric Coefficient of Variation 159.4
|
—
|
—
|
|
Maximum Concentration (Cmax) of Dabrafenib Metabolites
hydroxy-dabrafenib @ Week 1 Day 1
|
894 ng/mL
Geometric Coefficient of Variation 58.2
|
811 ng/mL
Geometric Coefficient of Variation 24.7
|
662 ng/mL
Geometric Coefficient of Variation 66.7
|
473 ng/mL
Geometric Coefficient of Variation 1643.7
|
1370 ng/mL
Geometric Coefficient of Variation 43.9
|
694 ng/mL
Geometric Coefficient of Variation 77.9
|
—
|
—
|
|
Maximum Concentration (Cmax) of Dabrafenib Metabolites
hydroxy-dabrafenib @ Week 3 Day 15
|
711 ng/mL
Geometric Coefficient of Variation 43.4
|
673 ng/mL
Geometric Coefficient of Variation 62.8
|
726 ng/mL
Geometric Coefficient of Variation 37.6
|
752 ng/mL
Geometric Coefficient of Variation 32.8
|
1010 ng/mL
Geometric Coefficient of Variation 51.5
|
772 ng/mL
Geometric Coefficient of Variation 50.1
|
—
|
—
|
|
Maximum Concentration (Cmax) of Dabrafenib Metabolites
carboxy-dabrafenib @ Week 1 Day 1
|
2330 ng/mL
Geometric Coefficient of Variation 97.6
|
1720 ng/mL
Geometric Coefficient of Variation 90.6
|
1300 ng/mL
Geometric Coefficient of Variation 55.7
|
824 ng/mL
Geometric Coefficient of Variation 291.3
|
4250 ng/mL
Geometric Coefficient of Variation 67.0
|
1650 ng/mL
Geometric Coefficient of Variation 161.2
|
—
|
—
|
|
Maximum Concentration (Cmax) of Dabrafenib Metabolites
carboxy-dabrafenib @ Week 3 Day 15
|
7970 ng/mL
Geometric Coefficient of Variation 30.0
|
4700 ng/mL
Geometric Coefficient of Variation 51.7
|
6410 ng/mL
Geometric Coefficient of Variation 28.0
|
9650 ng/mL
Geometric Coefficient of Variation 35.9
|
11200 ng/mL
Geometric Coefficient of Variation 28.4
|
8280 ng/mL
Geometric Coefficient of Variation 45.9
|
—
|
—
|
|
Maximum Concentration (Cmax) of Dabrafenib Metabolites
desmethyl-dabrafenib @ Week 3 Day 15
|
274 ng/mL
Geometric Coefficient of Variation 77.4
|
194 ng/mL
Geometric Coefficient of Variation 219.4
|
311 ng/mL
Geometric Coefficient of Variation 78.9
|
317 ng/mL
Geometric Coefficient of Variation 324.9
|
238 ng/mL
Geometric Coefficient of Variation 45.6
|
328 ng/mL
Geometric Coefficient of Variation 38.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1 Day 1, Week 3 Day 15Population: Pharmacokinetic population. For each parameter, only participants with an evaluable PK sample collected at each timepoint were included in the analysis.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Tmax was listed and summarized using descriptive statistics for dabrafenib and its metabolites (hydroxy-dabrafenib \[GSK2285403\], carboxy-dabrafenib \[GSK2298683\], and desmethyl-dabrafenib \[GSK2167542\]).
Outcome measures
| Measure |
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg
n=31 Participants
All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)
n=3 Participants
Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)
n=10 Participants
Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
n=8 Participants
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
n=6 Participants
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg
n=27 Participants
All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax) of Dabrafenib and Its Metabolites
carboxy-dabrafenib @ Week 3 Day 15
|
4.00 Hour (hr)
Interval 2.0 to 8.0
|
6.00 Hour (hr)
Interval 4.0 to 8.0
|
4.00 Hour (hr)
Interval 3.0 to 8.0
|
4.00 Hour (hr)
Interval 3.0 to 8.0
|
4.00 Hour (hr)
Interval 3.0 to 4.0
|
4.00 Hour (hr)
Interval 0.0 to 8.0
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax) of Dabrafenib and Its Metabolites
dabrafenib @ Week 1 Day 1
|
2.00 Hour (hr)
Interval 0.5 to 4.0
|
2.00 Hour (hr)
Interval 2.0 to 2.0
|
2.00 Hour (hr)
Interval 2.0 to 4.0
|
2.00 Hour (hr)
Interval 0.5 to 4.0
|
2.00 Hour (hr)
Interval 2.0 to 4.0
|
2.00 Hour (hr)
Interval 0.5 to 4.0
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax) of Dabrafenib and Its Metabolites
dabrafenib @ Week 3 Day 15
|
2.00 Hour (hr)
Interval 1.0 to 4.0
|
1.00 Hour (hr)
Interval 1.0 to 2.0
|
2.00 Hour (hr)
Interval 0.5 to 4.0
|
2.00 Hour (hr)
Interval 1.0 to 3.0
|
2.00 Hour (hr)
Interval 1.0 to 3.0
|
2.00 Hour (hr)
Interval 1.0 to 6.0
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax) of Dabrafenib and Its Metabolites
hydroxy-dabrafenib @ Week 1 Day 1
|
4.00 Hour (hr)
Interval 2.0 to 4.0
|
4.00 Hour (hr)
Interval 4.0 to 4.0
|
4.00 Hour (hr)
Interval 2.0 to 4.0
|
3.00 Hour (hr)
Interval 0.5 to 4.0
|
3.00 Hour (hr)
Interval 2.0 to 4.0
|
4.00 Hour (hr)
Interval 2.0 to 4.0
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax) of Dabrafenib and Its Metabolites
hydroxy-dabrafenib @ Week 3 Day 15
|
2.00 Hour (hr)
Interval 1.0 to 4.0
|
2.00 Hour (hr)
Interval 1.0 to 3.0
|
2.50 Hour (hr)
Interval 1.0 to 4.0
|
2.00 Hour (hr)
Interval 1.0 to 4.0
|
2.00 Hour (hr)
Interval 1.0 to 3.0
|
2.00 Hour (hr)
Interval 1.0 to 6.0
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax) of Dabrafenib and Its Metabolites
carboxy-dabrafenib @ Week 1 Day 1
|
4.00 Hour (hr)
Interval 4.0 to 4.0
|
4.00 Hour (hr)
Interval 4.0 to 4.0
|
4.00 Hour (hr)
Interval 4.0 to 4.0
|
4.00 Hour (hr)
Interval 4.0 to 4.0
|
4.00 Hour (hr)
Interval 4.0 to 4.0
|
4.00 Hour (hr)
Interval 0.5 to 4.0
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax) of Dabrafenib and Its Metabolites
desmethyl-dabrafenib @ Week 1 Day 1
|
4.00 Hour (hr)
Interval 4.0 to 4.0
|
4.00 Hour (hr)
Interval 4.0 to 4.0
|
4.00 Hour (hr)
Interval 4.0 to 4.0
|
4.00 Hour (hr)
Interval 4.0 to 4.0
|
4.00 Hour (hr)
Interval 4.0 to 4.0
|
4.00 Hour (hr)
Interval 0.5 to 4.0
|
—
|
—
|
|
Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax) of Dabrafenib and Its Metabolites
desmethyl-dabrafenib @ Week 3 Day 15
|
1.00 Hour (hr)
Interval 0.0 to 8.0
|
2.00 Hour (hr)
Interval 0.0 to 8.0
|
2.00 Hour (hr)
Interval 0.5 to 8.0
|
1.50 Hour (hr)
Interval 0.0 to 8.0
|
1.50 Hour (hr)
Interval 0.0 to 3.0
|
2.00 Hour (hr)
Interval 0.0 to 8.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 3 Day 15Population: Pharmacokinetic population. For each parameter, only participants with an evaluable PK sample collected were included in the analysis.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. T1/2 of dabrafenib and its metabolites (hydroxy-dabrafenib \[GSK2285403\], carboxy-dabrafenib \[GSK2298683\], and desmethyl-dabrafenib \[GSK2167542\]) was listed and summarized using descriptive statistics.
Outcome measures
| Measure |
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg
n=29 Participants
All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)
n=3 Participants
Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)
n=10 Participants
Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
n=8 Participants
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
n=6 Participants
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg
n=25 Participants
All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
|---|---|---|---|---|---|---|---|---|
|
Elimination Half Life (T½) of Dabrafenib and Its Metabolites
dabrafenib
|
2.54 Hour (hr)
Standard Deviation 2.44
|
1.98 Hour (hr)
Standard Deviation 0.687
|
2.85 Hour (hr)
Standard Deviation 1.58
|
2.74 Hour (hr)
Standard Deviation 0.840
|
1.56 Hour (hr)
Standard Deviation 0.359
|
3.03 Hour (hr)
Standard Deviation 2.27
|
—
|
—
|
SECONDARY outcome
Timeframe: From study treatment start date till 28 days safety follow-up, assessed up to approximately 90 monthsPopulation: Safety population. Deaths occurring more than 28 days after the last dose of study drug were not included in the on-treatment deaths. All deaths included on-treatment deaths and those occurring more than 28 days after the last dose of study drug.
The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Events, Serious Adverse Event and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
Outcome measures
| Measure |
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg
All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)
n=17 Participants
Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)
n=28 Participants
Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
n=11 Participants
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
n=2 Participants
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg
All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
|---|---|---|---|---|---|---|---|---|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 2 (Tumor Specific Expansion)
On-treatment deaths
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 2 (Tumor Specific Expansion)
Adverse Events (AEs)
|
—
|
17 Participants
|
26 Participants
|
11 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 2 (Tumor Specific Expansion)
AEs suspected to be drug related
|
—
|
16 Participants
|
26 Participants
|
11 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 2 (Tumor Specific Expansion)
All deaths
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 2 (Tumor Specific Expansion)
Serious Adverse Events (SAEs)
|
—
|
7 Participants
|
13 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 2 (Tumor Specific Expansion)
SAEs suspected to be drug related
|
—
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 2 (Tumor Specific Expansion)
Fatal SAEs
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 2 (Tumor Specific Expansion)
Fatal SAEs suspected to be drug related
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 2 (Tumor Specific Expansion)
AEs leading to discontinuation
|
—
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 2 (Tumor Specific Expansion)
AEs requiring dose interruptions
|
—
|
10 Participants
|
13 Participants
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 2 (Tumor Specific Expansion)
AEs requiring dose reductions
|
—
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Treatment Emergent Adverse Events (AEs) in Part 2 (Tumor Specific Expansion)
AEs requiring dose reductions or interruptions
|
—
|
10 Participants
|
13 Participants
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: All treated population
Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR).based on Response Assessment in Neuro-Oncology (RANO) criteria for Low Grade Glioma (LLG) and High Grade Glioma (HGG) subjects.
Outcome measures
| Measure |
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg
n=33 Participants
All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)
n=4 Participants
Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)
n=6 Participants
Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
n=6 Participants
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
n=17 Participants
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg
n=24 Participants
All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
|---|---|---|---|---|---|---|---|---|
|
Best Overall Response Based on Investigator Assessment Per Response Assessment in Neuro-Oncology (RANO) Criteria for Low Grade Glioma (LLG) Subjects
|
24 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
12 Participants
|
17 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: All treated population
Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR).based on Response Assessment in Neuro-Oncology (RANO) criteria for Low Grade Glioma (LLG) and High Grade Glioma (HGG) subjects.
Outcome measures
| Measure |
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg
All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)
n=3 Participants
Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)
n=4 Participants
Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
n=28 Participants
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
n=28 Participants
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg
n=35 Participants
All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
|---|---|---|---|---|---|---|---|---|
|
Best Overall Response Based on Investigator Assessment Per Response Assessment in Neuro-Oncology (RANO) Criteria for High Grade Glioma (HGG) Subjects
|
—
|
2 Participants
|
1 Participants
|
7 Participants
|
7 Participants
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1-Predose, 0.5, 2 and 4 hours post dose; Day 15-Predose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose.Population: All subjects who received at least one dose of dabrafenib in Part 1 and 2 and provided an evaluable PK profile. All trametinib and dabrafenib concentration-time data were combined and included in a population PK analysis that examined the influence of demographics on the PK of study treatment.
The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on total apparent clearance (CL/F) of dabrafenib estimated with the PopPK model is summarized in this record.
Outcome measures
| Measure |
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg
All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)
n=85 Participants
Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)
Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg
All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
|---|---|---|---|---|---|---|---|---|
|
Effect of Weight on Total Apparent Clearance (CL/F) of Dabrafenib Estimated With a PopPK Model
|
—
|
0.223 coefficient
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1-Predose, 0.5, 2 and 4 hours post dose; Day 15-Predose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose.Population: All subjects who received at least one dose of dabrafenib in Part 1 and 2 and provided an evaluable PK profile. All trametinib and dabrafenib concentration-time data were combined and included in a population PK analysis that examined the influence of demographics on the PK of study treatment.
The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on volume of distribution (V/F) of dabrafenib estimated with the PopPK model is summarized in this record.
Outcome measures
| Measure |
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg
All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)
n=85 Participants
Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)
Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg
All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
|---|---|---|---|---|---|---|---|---|
|
Effect of Weight on Volume of Distribution (V/F) of Dabrafenib Estimated With a PopPK Model
|
—
|
0.593 coefficient
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1-Predose, 0.5, 2 and 4 hours post dose; Day 15-Predose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose.Population: All subjects who received at least one dose of dabrafenib in Part 1 and 2 and provided an evaluable PK profile. The covariate weight did not meet the pre-specified criteria to be considered a significant covariate on Ka based on the goodness-of-fit plots and the decrease of the objective function provided by the PopPK software (NONMEM). Therefore, effect of weight on Ka could not be calculated.
The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on absorption rate (ka) of dabrafenib estimated with a PopPK model is summarized in this record.
Outcome measures
| Measure |
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg
All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)
n=85 Participants
Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)
Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg
All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
|---|---|---|---|---|---|---|---|---|
|
Effect of Weight on Absorption Rate (ka) of Dabrafenib Estimated With a PopPK Model
|
—
|
NA coefficient
N/A: covariate weight did not meet the pre-specified criteria required to calculate a result in the PopPK model
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1-Predose, 0.5, 2 and 4 hours post dose; Day 15-Predose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose.Population: All subjects who received at least one dose of dabrafenib in Part 1 and 2 and provided an evaluable PK profile. The covariate weight did not meet the pre-specified criteria to be considered a significant covariate based on the goodness-of-fit plots and the decrease of the objective function provided by the PopPK software (NONMEM). Therefore, effect of weight on coefficients for significant covariates of dabrafenib could not be calculated.
The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on coefficients for significant covariates of dabrafenib estimated with a PopPK model is summarized in this record.
Outcome measures
| Measure |
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg
All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)
n=85 Participants
Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)
Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg
All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
|---|---|---|---|---|---|---|---|---|
|
Effect of Weight on Coefficients for Significant Covariates of Dabrafenib Estimated With a PopPK Model
|
—
|
NA coefficient
N/A: covariate weight did not meet the pre-specified criteria required to calculate a result in the PopPK model
|
—
|
—
|
—
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: up to 360 weeks (on-treatment in Part I), up to 300 weeks (on-treatment in Part II), up to approximately 7 years (study duration)Population: Clinical database population; all treated patients.
On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks). Deaths post treatment survival follow up were collected after the on- treatment period, up to approximately 7 years. Patients who didn't die during the on-treatment period and had not stopped study participation at the time of data cut-off (end of study) were censored.
Outcome measures
| Measure |
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg
n=28 Participants
All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)
n=3 Participants
Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)
n=10 Participants
Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
n=8 Participants
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
n=6 Participants
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg
n=17 Participants
All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
n=11 Participants
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
n=2 Participants
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
|---|---|---|---|---|---|---|---|---|
|
All Collected Deaths in Parts I and II
On-treatment deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
All Collected Deaths in Parts I and II
Post-treatment deaths
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
All Collected Deaths in Parts I and II
All deaths
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)
Serious events: 7 serious events
Other events: 17 other events
Deaths: 0 deaths
Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)
Serious events: 13 serious events
Other events: 26 other events
Deaths: 0 deaths
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
Serious events: 6 serious events
Other events: 11 other events
Deaths: 0 deaths
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)
n=3 participants at risk
Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
|
Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)
n=10 participants at risk
Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
|
Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)
n=8 participants at risk
Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
|
Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)
n=6 participants at risk
Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
|
Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)
n=17 participants at risk
Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)
n=28 participants at risk
Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
n=11 participants at risk
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
n=2 participants at risk
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Blood culture positive
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Disease progression
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
14.3%
4/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
45.5%
5/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Corynebacterium infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Varicella
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Stroke-like migraine attacks after radiation therapy
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epstein-Barr virus associated lymphoma
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.7%
3/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Meningeal disorder
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Product Issues
Device occlusion
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
Other adverse events
| Measure |
Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)
n=3 participants at risk
Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
|
Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)
n=10 participants at risk
Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
|
Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)
n=8 participants at risk
Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
|
Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)
n=6 participants at risk
Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
|
Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)
n=17 participants at risk
Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)
n=28 participants at risk
Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)
n=11 participants at risk
Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)
n=2 participants at risk
Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
3/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
29.4%
5/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
14.3%
4/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
27.3%
3/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.7%
3/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Cardiac disorders
Tricuspid valve disease
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Endocrine disorders
Precocious puberty
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Eye disorders
Dark circles under eyes
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Eye disorders
Diplopia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Eye disorders
Hypermetropia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Eye disorders
Keratitis
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Eye disorders
Myopia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Eye disorders
Papilloedema
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Eye disorders
Periorbital swelling
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Eye disorders
Retinal exudates
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Eye disorders
Scleral disorder
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Eye disorders
Uveitis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Eye disorders
Vernal keratoconjunctivitis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
40.0%
4/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
23.5%
4/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.7%
3/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Cheilosis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
37.5%
3/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
36.4%
4/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
4/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
3/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
35.3%
6/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
14.3%
4/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
36.4%
4/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
5/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
7/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
36.4%
4/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Oral mucosal eruption
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
5/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
62.5%
5/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
66.7%
4/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
35.3%
6/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
35.7%
10/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
81.8%
9/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
21.4%
6/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Catheter site erythema
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Catheter site extravasation
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Chills
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Complication associated with device
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Facial pain
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Face oedema
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
60.0%
6/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
3/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
35.3%
6/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
39.3%
11/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
27.3%
3/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Feeling hot
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Localised oedema
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Malaise
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Pain
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Pyrexia
|
100.0%
3/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
5/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
87.5%
7/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
83.3%
5/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
64.7%
11/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
35.7%
10/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
36.4%
4/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
100.0%
2/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
General disorders
Xerosis
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Immune system disorders
Hypersensitivity
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Bronchitis
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Carbuncle
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
36.4%
4/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Ear infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
1/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Enterobiasis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Eye infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
30.0%
3/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Furuncle
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Impetigo
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Influenza
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.7%
3/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Otitis media
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
37.5%
3/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Pertussis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Pharyngitis
|
66.7%
2/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Pitted keratolysis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Pustule
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Rash pustular
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
14.3%
4/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
27.3%
3/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
1/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Skin bacterial infection
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.7%
3/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
3/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
17.6%
3/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
14.3%
4/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
27.3%
3/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
30.0%
3/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.7%
3/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
27.3%
3/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
23.5%
4/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Cafe au lait spots
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
23.5%
4/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
60.0%
6/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
37.5%
3/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
66.7%
4/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
41.2%
7/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
32.1%
9/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
45.5%
5/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Ephelides
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
27.3%
3/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
27.3%
3/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
27.3%
3/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
30.0%
3/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
37.5%
3/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
23.5%
4/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
14.3%
4/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
27.3%
3/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Keloid scar
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
30.0%
3/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
37.5%
3/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
14.3%
4/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Lentigo
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Nail pigmentation
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Papule
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Palmoplantar keratoderma
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
30.0%
3/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
29.4%
5/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
40.0%
4/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
3/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
35.3%
6/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
28.6%
8/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
27.3%
3/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Oculofacial paralysis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
30.0%
3/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
37.5%
3/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
29.4%
5/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.7%
3/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
4/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
30.0%
3/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
17.6%
3/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
23.5%
4/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hypertrophy
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
30.0%
3/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
30.0%
3/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
3/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
17.6%
3/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Surgical and medical procedures
Steroid therapy
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
14.3%
4/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
27.3%
3/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
3/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Tracheostomy infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
62.5%
5/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
14.3%
4/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
36.4%
4/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
23.5%
4/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Varicella
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Viral rash
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
37.5%
3/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Nail avulsion
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
40.0%
4/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
17.6%
3/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
27.3%
3/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
37.5%
3/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
27.3%
3/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Blood alkaline phosphatase decreased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Blood bilirubin decreased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Blood calcium decreased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Blood chloride increased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
17.6%
3/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
17.9%
5/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
45.5%
5/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Blood luteinising hormone increased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Blood prolactin abnormal
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Blood urea decreased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Carbon dioxide decreased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Cardiac murmur
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Creatinine urine decreased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
17.6%
3/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
37.5%
3/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Platelet count increased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Protein total increased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Protein urine present
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Red blood cell count increased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Respiratory rate decreased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
1/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Urine protein/creatinine ratio increased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
Weight increased
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
17.6%
3/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Investigations
White blood cell count decreased
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
36.4%
4/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
37.5%
3/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
66.7%
4/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
21.4%
6/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
30.0%
3/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
37.5%
3/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
17.6%
3/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.7%
3/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
27.3%
3/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
30.0%
3/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
30.0%
3/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
17.6%
3/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
3/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
66.7%
2/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
30.0%
3/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
4/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
3/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
17.6%
3/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
14.3%
4/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
45.5%
5/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
1/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
40.0%
4/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
23.5%
4/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
14.3%
4/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
30.0%
3/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.7%
3/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Ligament pain
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
30.0%
3/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal deformity
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
30.0%
3/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
40.0%
4/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
17.6%
3/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
14.3%
4/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
27.3%
3/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
17.6%
3/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
28.6%
8/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
36.4%
4/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Xanthogranuloma
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Altered state of consciousness
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
30.0%
3/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Dysmetria
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
80.0%
8/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
37.5%
3/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
47.1%
8/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
35.7%
10/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
36.4%
4/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Hemianopia
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Nervous system disorder
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Periodic limb movement disorder
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
14.3%
4/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
7.1%
2/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
VIth nerve paralysis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Psychiatric disorders
Agitation
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Psychiatric disorders
Anger
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
27.3%
3/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
18.2%
2/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Psychiatric disorders
Dysphemia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Psychiatric disorders
Mood altered
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Renal and urinary disorders
Dysuria
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
4/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
17.6%
3/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
14.3%
4/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Renal and urinary disorders
Renal tubular disorder
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
1/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
5/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
4/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
50.0%
3/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
17.6%
3/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
28.6%
8/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
54.5%
6/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
10.0%
1/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
17.6%
3/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypocapnia
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
5.9%
1/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
20.0%
2/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
25.0%
2/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
16.7%
1/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
11.8%
2/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
27.3%
3/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
1/3 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
30.0%
3/10 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
12.5%
1/8 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
33.3%
2/6 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/17 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
3.6%
1/28 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
9.1%
1/11 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
0.00%
0/2 • Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).
Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.
|
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 the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER